[Federal Register Volume 85, Number 6 (Thursday, January 9, 2020)]
[Notices]
[Pages 1160-1167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00120]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5254]


Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 
Abbreviated New Drug Applications; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is proposing to withdraw approval 
of 249 abbreviated new drug applications (ANDAs) from multiple holders 
of those ANDAs and is announcing an opportunity for the ANDA holders to 
request a hearing on this proposal. The basis for the proposal is that 
these ANDA holders have repeatedly failed to file required annual 
reports for those ANDAs.

DATES: The ANDA holders may submit a request for a hearing by February 
10, 2020. Submit all data, information, and analyses upon which the 
request for a hearing relies by March 9, 2020. Submit electronic or 
written comments by March 9, 2020.

ADDRESSES: The request for a hearing may be submitted by the ANDA 
holders by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments to submit your request 
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a 
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     Because your request for a hearing will be made public, 
you are solely responsible for ensuring that your request does not 
include any confidential information that you or a third party may not 
wish to be posted, such as medical information, your or anyone else's 
Social Security number, or confidential business information, such

[[Page 1161]]

as a manufacturing process. The request for a hearing must include the 
Docket No. FDA-2019-N-5254 for ``Fresenius USA, Inc., et al.; Proposal 
To Withdraw Approval of 249 ANDAs; Opportunity for a Hearing.'' The 
request for a hearing will be placed in the docket and publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
    The ANDA holders may submit all data and analyses upon which the 
request for a hearing relies in the same manner as the request for a 
hearing except as follows:
     Confidential Submissions--To submit any data analyses with 
confidential information that you do not wish to be made publicly 
available, submit your data and analyses only as a written/paper 
submission. You should submit two copies total of all data and 
analyses. One copy will include the information you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information, in its consideration of 
any decisions on this matter. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov 
or available at the Dockets Management Staff between 9 a.m. and 4 p.m., 
Monday through Friday. Submit both copies to the Dockets Management 
Staff. Any information marked as ``confidential'' will not be disclosed 
except in accordance with Sec.  10.20 (21 CFR 10.20) and other 
applicable disclosure law.
    Comments Submitted by Other Interested Parties: For all comments 
submitted by other interested parties, submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-5254 for ``Fresenius USA, Inc., et al.; Proposal To Withdraw 
Approval of 249 ANDAs; Opportunity for a Hearing.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with Sec.  10.20 and other applicable 
disclosure law. For more information about FDA's posting of comments to 
public dockets, see 80 FR 56469, September 18, 2015, or access the 
information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-7920, Martha.Nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The holders of approved ANDAs to market new 
drugs for human use are required to submit annual reports to FDA 
concerning each of their approved ANDAs under Sec. Sec.  314.81 and 
314.98 (21 CFR 314.81 and 314.98). The holders of the approved ANDAs 
listed in the following table have repeatedly failed to submit the 
required annual reports and have not responded to the Agency's request, 
sent by certified mail, for submission of the reports.

------------------------------------------------------------------------
      Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 020374...............  Inpersol-LC/LM With    Fresenius USA, Inc.,
                             Dextrose 1.5%          2637 Shadelands Dr.,
                             (calcium chloride,     Walnut Creek, CA
                             dextrose, magnesium    94598.
                             chloride, sodium
                             chloride, sodium
                             lactate)
                             Intraperitoneal
                             Solution, 18.4
                             milligrams (mg)/100
                             milliliters (mL);
                             1.5 grams (g)/100
                             mL; 5.08 mg/100 mL;
                             538 mg/100 mL; 448
                             mg/100 mL.

[[Page 1162]]

 
                            Inpersol-LC/LM With
                             Dextrose 2.5%
                             (calcium chloride,
                             dextrose, magnesium
                             chloride, sodium
                             chloride, sodium
                             lactate)
                             Intraperitoneal
                             Solution, 18.4 mg/
                             100 mL; 2.5 g/100
                             mL; 5.08 mg/100 mL;
                             538 mg/100 mL; 448
                             mg/100 mL.
                            Inpersol-LC/LM With
                             Dextrose 3.5%
                             (calcium chloride,
                             dextrose, magnesium
                             chloride, sodium
                             chloride, sodium
                             lactate)
                             Intraperitoneal
                             Solution, 18.4 mg/
                             100 mL; 3.5 g/100
                             mL; 5.08 mg/100 mL;
                             538 mg/100 mL; 448
                             mg/100 mL.
                            Inpersol-LC/LM With
                             Dextrose 4.25%
                             (calcium chloride,
                             dextrose, magnesium
                             chloride, sodium
                             chloride, sodium
                             lactate)
                             Intraperitoneal
                             Solution, 18.4 mg/
                             100 mL; 4.25 g/100
                             mL; 5.08 mg/100 mL;
                             538 mg/100 mL; 448
                             mg/100 mL.
ANDA 040057...............  Epinephrine and        Eastman Kodak Co.,
                             Lidocaine              343 State St.,
                             Hydrochloride (HCl)    Rochester, NY 14650.
                             Injection, 0.01 mg/
                             mL; 2% and 0.02 mg/
                             mL; 2%.
ANDA 040168...............  Hydrocortisone and     Wockhardt EU
                             Acetic Acid Otic       Operations (Swiss)
                             Solution USP, 1%/2%.   AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc., 6451 West Main
                                                    St., Morton Grove,
                                                    IL 60053.
ANDA 040192...............  Prednisolone Syrup,    WE Pharmaceuticals,
                             15 mg/5 mL.            Inc., 1142 D St.,
                                                    P.O. Box 1142,
                                                    Ramona, CA 92065.
ANDA 060074...............  Penicillin G           Pfizer Laboratories,
                             Potassium for          Division of Pfizer,
                             Injection,             Inc., 235 East 42nd
                             20,000,000 units/      St., New York, NY
                             vial.                  10017.
ANDA 060131...............  Tetracycline HCl       Leiner Health
                             Capsules.              Products, Inc., 901
                                                    East 233rd St.,
                                                    Carson, CA 90745.
ANDA 060461...............  Neomycin Sulfate       Ambix Laboratories,
                             Ointment; Neomycin     Division of Organics
                             Sulfate and            Corp. of America,
                             Hydrocortisone         210 Orchard St.,
                             Acetate Ointment.      East Rutherford, NJ
                                                    07073.
ANDA 060521...............  Humatin (paromomycin   Parkedale
                             sulfate) Capsules      Pharmaceuticals,
                             USP, Equivalent to     Inc., 501 5th St.,
                             (EQ) 250 mg base.      Bristol, TN 37620.
ANDA 060602...............  Penicillin G           John D. Copanos and
                             Potassium Powder.      Co., Inc., 6110
                                                    Robinwood Rd.,
                                                    Baltimore, MD 21225.
ANDA 060627...............  Tribiotic (polymyxin   Ambix Laboratories,
                             B sulfate,             Division of Organics
                             bacitracin, and        Corp. of America.
                             neomycin sulfate)
                             Ointment, 5000 units/
                             400 units/5 mg.
ANDA 060709...............  Oleandomycin           Roerig, Division of
                             Injection.             Pfizer, Inc., 235
                                                    East 42nd St., New
                                                    York, NY 10017.
ANDA 060724...............  Pyocidin-HC (neomycin  Kasco-EFCO
                             sulfate, polymyxin B   Laboratories, Inc.,
                             sulfate, and           Cantiague Rock Rd.,
                             hydrocortisone) Otic   Hicksville, NY
                             Solution.              11802.
ANDA 060769...............  Tetracycline Syrup...  West-Ward
                                                    Pharmaceutical
                                                    Corp., 465
                                                    Industrial Way West,
                                                    Eatontown, NJ 07724.
ANDA 060773...............  Tetracycline Syrup...  Leiner Health
                                                    Products, Inc.
ANDA 060870...............  Oxytetracycline        Proter S.p.A., c/o
                             Injection.             Richmar
                                                    International, Inc.,
                                                    1706 Birch Rd.,
                                                    McLean, VA 22101.
ANDA 061034...............  Lincomycin HCl Powder  Pharmacia and Upjohn
                                                    Co., 7171 Portage
                                                    Rd., Kalamazoo, MI
                                                    49001.
ANDA 061064...............  Nystatin Ointment....  Lederle Laboratories,
                                                    Division of American
                                                    Cyanamid Co., 401
                                                    North Middletown
                                                    Rd., Pearl River, NY
                                                    10965.
ANDA 061087...............  Benzocaine,            Pfizer Laboratories,
                             Oxytetracycline HCl,   Division of Pfizer,
                             and Polymyxin B        Inc.
                             Sulfate Otic
                             Solution.
ANDA 061154...............  Hydrocortisone         Ambix Laboratories,
                             Acetate and Neomycin   Division of Organics
                             Sulfate Ointment.      Corp. of America.
ANDA 061209...............  Bacitracin Ointment     Do.
                             USP, 500 units/g.
ANDA 061228...............  Griseofulvin Capsules  Owen Laboratories,
                                                    Division of Alcon
                                                    Laboratories, 3737
                                                    Beltline Rd.,
                                                    Dallas, TX 75234.
ANDA 061483...............  Penicillin G           Leiner Health
                             Potassium Tablets.     Products, Inc.
ANDA 061518...............  Bacitracin Zinc        Rexall Drug Co., 135
                             Ointment.              Chesterfield
                                                    Industrial Blvd.,
                                                    Chesterfield, MO
                                                    63017.
ANDA 061519...............  Bacitracin Zinc and     Do.
                             Neomycin Sulfate
                             Ointment.
ANDA 061520...............  Bacitracin Zinc and     Do.
                             Neomycin Sulfate/
                             Polymyxin B Sulfate
                             Ointment.
ANDA 061521...............  Bacitracin Zinc,        Do.
                             Benzocaine, and
                             Neomycin Sulfate/
                             Polymyxin B Sulfate
                             Ointment.
ANDA 061528...............  Penicillin V           American Antibiotics,
                             Potassium Tablets      Inc., 6110 Robinwood
                             USP, EQ 250 mg base    Rd., Baltimore, MD
                             and EQ 500 mg base.    21225.
ANDA 061529...............  Penicillin V            Do.
                             Potassium for Oral
                             Solution USP, EQ 125
                             mg base/5 mL and EQ
                             250 mg base/5 mL.
ANDA 061532...............  Ampicillin Trihydrate  Leiner Health
                             Capsules.              Products, Inc.
ANDA 061601...............  Ampicillin for Oral    American Antibiotics,
                             Suspension USP, EQ     Inc.
                             125 mg base/5 mL and
                             EQ 250 mg base/5 mL.
ANDA 061602...............  Ampicillin Capsules     Do.
                             USP, EQ 250 mg base
                             and EQ 500 mg base.
ANDA 061632...............  Ampicillin Trihydrate  Chromalloy
                             Capsules, 250 mg.      Pharmaceuticals,
                                                    Inc., 5353 Grosvenor
                                                    Blvd., Los Angeles,
                                                    CA 90066.
ANDA 061652...............  Oxytetracycline        Warner-Lambert Co.,
                             Capsules.              201 Tabor Rd.,
                                                    Morris Plains, NJ
                                                    07950.
ANDA 061674...............  Penicillin V           Leiner Health
                             Potassium Tablets.     Products, Inc.

[[Page 1163]]

 
ANDA 061697...............  Griseofulvin Capsules  Watson Laboratories,
                                                    Inc., 311 Bonnie
                                                    Cir., Corona, CA
                                                    92880.
ANDA 061699...............  Bacitracin Powder for  Apothekernes
                             Rx Compounding,        Laboratorium A.S., c/
                             5,000,000 units/       o AL Laboratories,
                             bottle.                Inc., 1 Executive
                                                    Dr., Fort Lee, NJ
                                                    07024.
ANDA 061701...............  Tetracycline Syrup,    AH Robins Co., 1211
                             125 mg/5 mL.           Sherwood Ave.,
                                                    Richmond, VA 23220.
ANDA 061725...............  Cyclopar               Warner-Lambert Co.
                             (tetracycline HCl)
                             Capsules USP, 250 mg
                             and 500 mg.
ANDA 061833...............  Oxytetracycline HCl    Pliva, c/o Transtrade
                             Capsules, 250 mg.      USA, Ltd., 515
                                                    Madison Ave., 4th
                                                    Floor East, New
                                                    York, NY 10022.
ANDA 061847...............  Bleomycin Sulfate      Takasaki Plant,
                             Injection.             Nippon Kayaku Co.,
                                                    Ltd., 500 5th Ave.,
                                                    Suite 1726, New
                                                    York, NY 10110.
ANDA 061857...............  Penicillamine Powder.  Chemiewerk Homberg, c/
                                                    o Wallace
                                                    Laboratories,
                                                    Cranbury, NJ 08512.
ANDA 061903...............  Bacitracin Zinc and    Ambix Laboratories,
                             Polymyxin B Sulfate    Division of Organics
                             Ointment.              Corp. of America.
ANDA 061943...............  Chloramphenicol        Lederle Laboratories,
                             Ophthalmic Solution,   Division of American
                             0.5%.                  Cyanamid Co., 1
                                                    Cyanamid Plaza,
                                                    Wayne, NJ 07470.
ANDA 062032...............  Erythromycin Stearate  Warner-Lambert Co.
                             Tablets, EQ 250 mg
                             base and EQ 500 mg
                             base.
ANDA 062085...............  Tetracycline HCl       MM Mast and Co., 4152
                             Capsules, 250 mg.      Ruple Rd.,
                                                    Cleveland, OH 44121.
ANDA 062175...............  Tetracycline HCl       Warner-Lambert Co.
                             Capsules, 250 mg.
ANDA 062205...............  Cefaclor Capsules      Ceph International
                             USP, EQ 250 mg base    Corp. c/o Mova
                             and EQ 500 mg base.    Pharmaceutical
                                                    Corp., State Rd #1
                                                    Jose Garrido St.,
                                                    Cagus, PR 00725.
ANDA 062215...............  Oxytetracycline HCl    Lederle Laboratories,
                             Capsules.              Division of American
                                                    Cyanamid Co., Pearl
                                                    River, NY 10965-
                                                    1215.
ANDA 062340...............  Gentamicin Sulfate     Pharmaceutical
                             Injection.             Specialist
                                                    Association, 9852
                                                    Cowden St.,
                                                    Philadelphia, PA
                                                    19115.
ANDA 062467...............  E-Solve 2              Syosset Laboratories,
                             (erythromycin)         Inc., 150 Eileen
                             Lotion, 2%.            Way, Syosset, NY
                                                    11791.
ANDA 062758...............  Eryzole (erythromycin  Alra Laboratories,
                             ethylsuccinate and     Inc., 3850 Clearview
                             sulfisoxazole          Ct., Gurnee, IL
                             acetyl) Granules, EQ   60031.
                             200 mg base/5 mL; EQ
                             600 mg base/5 mL.
ANDA 062869...............  Cephalexin Capsules    Jerome Stevens
                             USP, EQ 500 mg base.   Pharmaceuticals
                                                    Inc., 60 DaVinci
                                                    Dr., Bohemia, NY
                                                    11716.
ANDA 062870...............  Cephalexin Capsules     Do.
                             USP, EQ 250 mg base.
ANDA 062944...............  Clindamycin Phosphate  BOCA Pharmacal, LLC.,
                             Topical Solution       3550 North West
                             USP, EQ 1% base.       126th Ave., Coral
                                                    Springs, FL 33065.
ANDA 070104...............  Chlorhexidine          Matrix Medical Corp.,
                             Gluconate Topical      1825 South 3730
                             Solution, 4%.          West, Salt Lake
                                                    City, UT 84104.
ANDA 071054...............  Constilac (lactulose)  Alra Laboratories,
                             Solution, 10 g/15 mL.  Inc.
ANDA 071057...............  Ibu-tab 200             Do.
                             (ibuprofen) Tablets,
                             200 mg.
ANDA 071058...............  Ibu-tab (ibuprofen)     Do.
                             Tablets, 400 mg.
ANDA 071059...............  Ibu-tab (ibuprofen)     Do.
                             Tablets, 600 mg.
ANDA 071104...............  Leucovorin Calcium     Xanodyne Pharmacal,
                             Tablets, EQ 15 mg      Inc., 7310 Turfway
                             base.                  Rd., Suite 490,
                                                    Florence, KY 41042.
ANDA 071139...............  Trazodone HCl          American
                             Tablets, 50 mg.        Therapeutics, Inc.,
                                                    89 Carlough Rd.,
                                                    Bohemia, NY 11716.
ANDA 071140...............  Trazodone HCl           Do.
                             Tablets, 100 mg.
ANDA 071331...............  Cholac (lactulose)     Alra Laboratories,
                             Solution, 10 g/15 mL.  Inc.
ANDA 071362...............  Meclofenamate Sodium   American
                             Capsules USP, 50 mg.   Therapeutics, Inc.
ANDA 071363...............  Meclofenamate Sodium    Do.
                             Capsules USP, 100 mg.
ANDA 071419...............  Brian Care             Soapco, Inc., P.O.
                             (chlorhexidine         Box 5490,
                             gluconate) Topical     Pleasanton, CA
                             Solution, 4%.          94566.
ANDA 071429...............  Clorazepate            American
                             Dipotassium            Therapeutics, Inc.
                             Capsules, 3.75 mg.
ANDA 071430...............  Clorazepate             Do.
                             Dipotassium
                             Capsules, 7.5 mg.
ANDA 071431...............  Clorazepate             Do.
                             Dipotassium
                             Capsules, 15 mg.
ANDA 071569...............  Danazol Capsules USP,   Do.
                             200 mg.
ANDA 071787...............  Gen-Xene (clorazepate  Alra Laboratories,
                             dipotassium)           Inc.
                             Tablets, 3.75 mg.
ANDA 071788...............  Gen-Xene (clorazepate   Do.
                             dipotassium)
                             Tablets, 7.5 mg.
ANDA 071789...............  Gen-Xene (clorazepate   Do.
                             dipotassium)
                             Tablets, 15 mg.
ANDA 071955...............  Oxazepam Capsules      American
                             USP, 10 mg.            Therapeutics, Inc.
ANDA 071956...............  Oxazepam Capsules       Do.
                             USP, 15 mg.
ANDA 071957...............  Oxazepam Capsules       Do.
                             USP, 30 mg.
ANDA 071962...............  Leucovorin Calcium     Xanodyne Pharmacal,
                             Tablets, EQ 10 mg      Inc.
                             base.
ANDA 071965...............  Ibu-tab (ibuprofen)    Alra Laboratories,
                             Tablets, 800 mg.       Inc.
ANDA 072022...............  Triamterene and        American
                             Hydrochlorothiazide    Therapeutics, Inc.
                             Tablets, 75 mg/50 mg.
ANDA 072129...............  Maprotiline HCl         Do.
                             Tablets USP, 25 mg.
ANDA 072130...............  Maprotiline HCl         Do.
                             Tablets USP, 50 mg.
ANDA 072131...............  Maprotiline HCl         Do.
                             Tablets USP, 75 mg.
ANDA 072190...............  Metaproterenol         Wockhardt EU
                             Sulfate Inhalation     Operations (Swiss)
                             Solution, 5%.          AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
ANDA 072196...............  Milophene (clomiphene  Milex Products, Inc.,
                             citrate) Tablets, 50   5915 Northwest
                             mg.                    Highway, Chicago, IL
                                                    60631.
ANDA 072255...............  Microderm              Johnson and Johnson
                             (chlorhexidine         Medical, Inc., 2500
                             gluconate) Topical     Arbrook Blvd.,
                             Solution, 4%.          Arlington, TX 76014.

[[Page 1164]]

 
ANDA 072292...............  Prevacare R             Do.
                             (chlorhexidine
                             gluconate) Topical
                             Solution, 0.5%.
ANDA 072295...............  Microderm               Do.
                             (chlorhexidine
                             gluconate) Topical
                             Sponge, 4%.
ANDA 072307...............  Fenoprofen Calcium     American
                             Capsules USP, 200 mg.  Therapeutics, Inc.
ANDA 072308...............  Fenoprofen Calcium      Do.
                             Capsules USP, 300 mg.
ANDA 072309...............  Fenoprofen Calcium      Do.
                             Tablets USP, 600 mg.
ANDA 072782...............  Prazosin HCl Capsules   Do.
                             USP, 1 mg.
ANDA 072783...............  Prazosin HCl Capsules   Do.
                             USP, 2 mg.
ANDA 072784...............  Prazosin HCl Capsules   Do.
                             USP, 5 mg.
ANDA 073416...............  E-Z Scrub              Becton Dickinson
                             (chlorhexidine         Surgical System,
                             gluconate) Topical     9450 South State
                             Sponge, 4%.            St., Sandy, UT
                                                    84070.
ANDA 073535...............  Piroxicam Capsules,    Mutual Pharmaceutical
                             10 mg.                 Co., Inc., 1100
                                                    Orthodox St.,
                                                    Philadelphia, PA
                                                    19124.
ANDA 074523...............  Metromidol             Laboratorios
                             (metronidazole)        Applicaciones
                             Tablets, 250 mg and    Farmaceuticas S.A.
                             500 mg.                de CV, c/o Richard
                                                    Hamer Association,
                                                    Inc., P.O. Box
                                                    16598, Fort Worth,
                                                    TX 76162.
ANDA 074560...............  Flurbiprofen Tablets   Theragen, Inc., 10
                             USP, 100 mg.           Lake Dr., East
                                                    Windsor, NJ 08520.
ANDA 074702...............  Metaproterenol         Wockhardt EU
                             Sulfate Syrup, 10 mg/  Operations (Swiss)
                             5 mL.                  AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
ANDA 074881...............  Iopamidol Injection,   Cook Imaging Corp.,
                             41%, 51%, 61%, and     927 South Curry
                             76%.                   Pike, P.O. Box 3068,
                                                    Bloomington, IN
                                                    47403.
ANDA 074988...............  Aspirin, Caffeine,     Jerome Stevens
                             and Orphenadrine       Pharmaceuticals,
                             Citrate Tablets, 385   Inc.
                             mg/30 mg/25 mg and
                             770 mg/60 mg/50 mg.
ANDA 075181...............  Prednisolone Sodium    WE Pharmaceuticals,
                             Phosphate Oral         Inc.
                             Solution, EQ 5 mg
                             base/5 mL.
ANDA 075260...............  Tretinoin Topical      Wockhardt EU
                             Solution, 0.05%.       Operations (Swiss)
                                                    AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
ANDA 075414...............  Nifedipine Extended-   Martec USA, LLC, 1800
                             Release Tablets, 90    North Topping Ave.,
                             mg.                    Kansas City, MO
                                                    64120.
ANDA 075507...............  Ipratropium Bromide    Pharmascience, Inc.,
                             Inhalation Solution,   10 Orchard Pl.,
                             0.02%.                 Tenafly City, NJ
                                                    07670.
ANDA 075569...............  Thallous Chloride TL   Trace Life Sciences,
                             201 Injection USP, 1   Inc., 2101 Shady
                             millicurie (mCi)/mL.   Oaks, Denton, TX
                                                    76205.
ANDA 075586...............  Metaproterenol         Wockhardt EU
                             Sulfate Inhalation     Operations (Swiss)
                             Solution, 0.4% and     AG, c/o Morton Grove
                             0.6%.                  Pharmaceuticals,
                                                    Inc.
ANDA 075619...............  Minoxidil Extra        Avacor Products, LLC,
                             Strength (for Men)     227 East 56th St.,
                             Topical Solution, 5%.  3rd Floor, New York,
                                                    NY 10022.
ANDA 075766...............  Calcitriol Injection,  Fresenius Medical
                             1 microgram (mcg)/mL   Care North America,
                             and 2 mcg/mL.          95 Hayden Ave.,
                                                    Lexington, MA 02421.
ANDA 075941...............  Strontium Chloride SR- Bio-Nucleonics, Inc.,
                             89 Injection, 1 mCi/   1600 Market St.,
                             mL.                    Suite 13200,
                                                    Philadelphia, PA
                                                    19103.
ANDA 077072...............  Ipratropium Bromide    Landela
                             Inhalation Solution,   Pharmaceutical, 776
                             0.02%.                 East Riverside Dr.,
                                                    Suite 150, Eagle, ID
                                                    83616.
ANDA 077218...............  ThyroShield            Arco Pharmaceuticals,
                             (potassium iodide)     LLC, 7605 Maryland
                             Oral Solution USP,     Ave., St. Louis, MO
                             65 mg/mL.              63105.
ANDA 077569...............  Albuterol Sulfate      Landela
                             Inhalation Solution,   Pharmaceutical.
                             EQ 0.083% base.
ANDA 080024...............  Sulfacel-15            Optopics Laboratories
                             (sulfacetamide         Corp., P.O. Box 210,
                             sodium) Ophthalmic     Fairton, NJ 08320.
                             Solution, 15%.
ANDA 080036...............  Sosol (sulfisoxazole)  MK Laboratories,
                             Tablets, 500 mg.       Inc., 424 Grasmere
                                                    Ave., Fairfield, CT
                                                    06430.
ANDA 080366...............  Soxazole               Alra Laboratories,
                             (sulfisoxazole)        Inc.
                             Tablets, 500 mg.
ANDA 080380...............  Bamate (meprobamate)    Do.
                             Tablets, 200 mg and
                             400 mg.
ANDA 080483...............  Hi-cor                 C and M Pharmacal,
                             (hydrocortisone)       Inc., 1519 East 8
                             Cream, 2.5%.           Mile Rd., Hazel
                                                    Park, MI 48030.
ANDA 080492...............  Reserpine Tablets,     Marshall Pharmacal
                             0.1 mg and 0.25 mg.    Corp., 89 Michael
                                                    St., South
                                                    Hackensack, NJ
                                                    07606.
ANDA 080518...............  Dimenhydrinate         Alra Laboratories,
                             Tablets, 50 mg.        Inc.
ANDA 080519...............  Diphenhydramine HCl     Do.
                             Capsules, 25 mg and
                             50 mg.
ANDA 080525...............  Reserpine Tablets,     MK Laboratories, Inc.
                             0.1 mg and 0.25 mg.
ANDA 080592...............  Diphenhydramine HCl    Valeant
                             Capsules, 50 mg.       Pharmaceuticals
                                                    International, One
                                                    Enterprise, Aliso
                                                    Viejo, CA 92656.
ANDA 080660...............  Ocusulf                Miza Pharmaceuticals
                             (sulfacetamide         USA, Inc., c/o
                             sodium) Ophthalmic     Optopics
                             Solution, 10% and      Laboratories, 40
                             30%.                   Main St., P.O. Box
                                                    210, Fairton, NJ
                                                    08320.
ANDA 080714...............  Diphenhydramine HCl    Alra Laboratories,
                             Oral Solution, 12.5    Inc.
                             mg/5 mL.
ANDA 080715...............  Dimenhydrinate Oral     Do.
                             Solution, 12.5 mg/4
                             mL.
ANDA 080941...............  Isoniazid Tablets,     MK Laboratories, Inc.
                             100 mg.
ANDA 080970...............  Methscopolamine        Private Formulations,
                             Bromide Tablets, 2.5   Inc., 460 Plainfield
                             mg.                    Ave., Edison, NJ
                                                    08818.
ANDA 081145...............  Aspirin and            Jerome Stevens
                             Methocarbamol          Pharmaceuticals,
                             Tablets, 325 mg/400    Inc.
                             mg.
ANDA 083001...............  Triamcinolone          Lederle Laboratories,
                             Acetonide Aerosol      Division of American
                             Foam Emulsion.         Cyanamid Co., Pearl
                                                    River, NY 10965-
                                                    1215.
ANDA 083087...............  Diphenhydramine HCl    MK Laboratories, Inc.
                             Capsules, 25 mg and
                             50 mg.
ANDA 083088...............  Diphenhydramine HCl     Do.
                             Elixir, 12.5 mg/5 mL.
ANDA 083264...............  Pentobarbital Sodium   Valeant
                             Capsules, 100 mg.      Pharmaceuticals
                                                    International.

[[Page 1165]]

 
ANDA 083286...............  Chlorpheniramine       Marshall Pharmacal
                             Maleate Tablets.       Corp.
ANDA 083315...............  Procaine HCl           Elkins Sinn
                             Injection, 1% and 2%.  Pharmaceutical Co.,
                                                    c/o ESI Lederle, 2
                                                    Esterbrook Ln.,
                                                    Cherry Hill, NJ
                                                    08003.
ANDA 083320...............  Acetazolamide          Alra Laboratories,
                             Tablets, 250 mg.       Inc.
ANDA 083389...............  Epinephrine and        Dell Laboratories,
                             Lidocaine HCl          Inc., 668 Front St.,
                             Injection, 0.01 mg/    Teaneck, NJ 07666.
                             mL and 1%.
ANDA 083390...............  Epinephrine and         Do.
                             Lidocaine HCl
                             Injection, 0.01 mg/
                             mL and 2%.
ANDA 083457...............  Vitamin A Palmitate    MK Laboratories, Inc.
                             Capsules, EQ 25,000
                             units base and EQ
                             50,000 units base.
ANDA 083524...............  Butabarbital Sodium    Marshall Pharmacal
                             Tablets, 16.2 mg.      Corp.
ANDA 083525...............  Niacin Tablets, 500    MK Laboratories, Inc.
                             mg.
ANDA 083526...............  Folic Acid Tablets, 1   Do.
                             mg.
ANDA 083658...............  Promethazine HCl       Private Formulations,
                             Tablets, 25 mg.        Inc.
ANDA 083806...............  Dexamethasone          Phoenix Laboratories,
                             Tablets, 0.75 mg.      Inc., 175 Lauman
                                                    Ln., East
                                                    Hicksville, NY
                                                    11801.
ANDA 083827...............  Pramine (imipramine    Alra Laboratories,
                             HCl) Tablets, 10 mg,   Inc.
                             25 mg, and 50 mg.
ANDA 083858...............  Butabarbital Sodium    Marshall Pharmacal
                             Tablets, 32.4 mg.      Corp.
ANDA 083863...............  Sulfisoxazole Cream..  Holland Rantos Co.,
                                                    Inc., P.O. Box 385,
                                                    Piscataway, NJ
                                                    08854.
ANDA 084185...............  Bethanechol Chloride   Wendt Laboratories,
                             Tablets, 10 mg.        Inc., 200 West
                                                    Beaver, P.O. Box
                                                    128, Belle Plaine,
                                                    MN 56011.
ANDA 084186...............  Bethanechol Chloride    Do.
                             Tablets, 25 mg.
ANDA 084188...............  Myotonachol            Glenwood, Inc., 83
                             (bethanechol           North Summit St.,
                             chloride) Tablets, 5   P.O. Box 518,
                             mg, 10 mg, and 25 mg.  Tenafly, NJ 07670.
ANDA 084246...............  Cortisone Acetate      Everylife, 2021 15th
                             Tablets, 25 mg.        Ave., West Seattle,
                                                    WA 98119.
ANDA 084439...............  Prednisolone Tablets,   Do.
                             1 mg, 2.5 mg, and 5
                             mg.
ANDA 084440...............  Prednisone Tablets, 1   Do.
                             mg, 2.5 mg, and 5 mg.
ANDA 084494...............  Hydrochlorothiazide    West-Ward
                             Tablets.               Pharmaceutical Corp.
ANDA 084590...............  Pentobarbital Sodium   Anabolic, Inc., 1835
                             Capsules, 100 mg.      East Cheyenne Rd.,
                                                    Colorado Springs, CO
                                                    80905.
ANDA 084631...............  Quinidine Sulfate      Sandoz, Inc., 4700
                             Tablets USP, 200 mg.   Eon Dr., Wilson, NC
                                                    27893.
ANDA 084687...............  Niacin Tablets, 500    Zzeon
                             mg.                    Pharmaceuticals,
                                                    Ltd., Jamboree at
                                                    Kevin, Irvine, CA
                                                    92705,
ANDA 084714...............  Hydro-Reserp           ABC Holding Corp.,
                             (hydrochlorothiazide   P.O. Box 307, 70945
                             and reserpine)         Van Dyke Ave.,
                             Tablets, 50 mg/0.125   Romeo, MI 48065.
                             mg.
ANDA 084729...............  Lidocaton              Pharmaton, Ltd., c/o
                             (epinephrine and       Bass Ullmna and
                             lidocaine HCl)         Lustigman, 747 3rd
                             Injection, 0.01 mg/    Ave., New York, NY
                             mL and 2%.             10017.
ANDA 084803...............  Chlorpromazine HCl     Lederle Laboratories,
                             Tablets, 10 mg.        Division of American
                                                    Cyanamid Co., Pearl
                                                    River, NY 10965-
                                                    1215.
ANDA 084872...............  Meclizine HCl          CM Bundy Co., 2055
                             Tablets, 25 mg.        Reading Rd.,
                                                    Cincinnati, OH
                                                    45205.
ANDA 084902...............  Promethacon            Polymedica
                             (promethazine HCl)     Industries, Inc., 2
                             Suppository, 50 mg.    Constitution Way,
                                                    Woburn, MA 01801.
ANDA 084931...............  Methamphetamine HCl    Rexar Pharmacal, 396
                             Tablets, 5 mg and 10   Rockaway Ave.,
                             mg.                    Valley Stream, NY
                                                    11581.
ANDA 084933...............  Diethylstilbestrol     West-Ward
                             Tablets, 1 mg.         Pharmaceutical Corp.
ANDA 084977...............  Halothane Inhalation,  BH Chemicals, Inc.,
                             99.99%.                500 5th Ave., New
                                                    York, NY 10036.
ANDA 085009...............  Lygen                  Alra Laboratories,
                             (chlordiazepoxide      Inc.
                             HCl) Capsules, 10 mg.
ANDA 085039...............  Folic Acid Tablets     Wendt Laboratories,
                             USP, 1 mg.             Inc.
ANDA 085040...............  Isoniazid Tablets       Do.
                             USP, 100 mg.
ANDA 085041...............  Meclizine HCl           Do.
                             Tablets, 25 mg.
ANDA 085042...............  Methocarbamol Tablets   Do.
                             USP, 500 mg.
ANDA 085044...............  Reserpine Tablets       Do.
                             USP, 0.25 mg.
ANDA 085075...............  Aerolate III           Fleming and Co.
                             (theophylline)         Pharmaceuticals,
                             Extended-Release       Inc., 1600 Fenton
                             Capsules, 65 mg.       Park Dr., Fenton, MO
                                                    63026.
                            Aerolate JR
                             (theophylline)
                             Extended-Release
                             Capsules, 130 mg..
                            Aerolate SR
                             (theophylline)
                             Extended-Release
                             Capsules, 260 mg..
ANDA 085107...............  Lygen                  Alra Laboratories,
                             (chlordiazepoxide      Inc.
                             HCl) Capsules, 5 mg.
ANDA 085108...............  Lygen                   Do.
                             (chlordiazepoxide
                             HCl) Capsules, 25 mg.
ANDA 085125...............  Methyltestosterone     Tablicaps, Inc., P.O.
                             Sublingual Tablets,    Box 5555,
                             10 mg.                 Franklinville, NJ
                                                    08322.
ANDA 085217...............  Acetaminophen and      Everylife.
                             Codeine Phosphate
                             Tablets, 325 mg/30
                             mg.
ANDA 085235...............  Chlordiazepoxide HCl   Abbott Laboratories,
                             Capsules.              Pharmaceutical
                                                    Products Division,
                                                    100 Abbott Park Rd.,
                                                    Abbott Park, IL
                                                    60064.
ANDA 085236...............  Chlordiazepoxide HCl    Do.
                             Capsules.
ANDA 085252...............  Meclizine HCl          ABC Holding Corp.
                             Tablets, 25 mg.
ANDA 085253...............  Meclizine HCl           Do.
                             Tablets, 12.5 mg.
ANDA 085282...............  Hydrocortisone         Mericon Industries,
                             Lotion, 0.5% and 1%.   Inc., 8819 North
                                                    Pioneer Rd., Peoria,
                                                    IL 61615.
ANDA 085383...............  Butabarbital Sodium    Wockhardt EU
                             Elixir, 30 mg/5 mL.    Operations (Swiss)
                                                    AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.

[[Page 1166]]

 
ANDA 085411...............  Phentermine HCl        ABC Holding Corp.
                             Capsules, 30 mg.
ANDA 085511...............  Cam-Metrazine           Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 085512...............  Phenazine-35            Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 085550...............  Butabarbital Sodium    CM Bundy Co.
                             Tablets, 30 mg.
ANDA 085569...............  Chlorothiazide         ABC Holding Corp.
                             Tablets, 250 mg.
ANDA 085587...............  Meclizine              Camall Co., Inc.,
                             Hydrochloride          60950 Van Dyke Ave.,
                             Chewable Tablets.      P.O. Box 218,
                                                    Washington, MI
                                                    48094.
ANDA 085638...............  Codeine, Aspirin,      Scherer Laboratories,
                             APAP Formula No. 4     Inc., 2301 Ohio Dr.,
                             (codeine phosphate,    Suite 234, Plano, TX
                             aspirin, and           75093.
                             acetaminophen)
                             Capsules, 60 mg/180
                             mg/150 mg.
ANDA 085639...............  Codeine, Aspirin,       Do.
                             APAP Formula No. 3
                             (codeine phosphate,
                             aspirin, and
                             acetaminophen)
                             Capsules, 30 mg/180
                             mg/150 mg.
ANDA 085640...............  Codeine, Aspirin,       Do.
                             APAP Formula No. 2
                             (codeine phosphate,
                             aspirin, and
                             acetaminophen)
                             Capsules, 15 mg/180
                             mg/150 mg.
ANDA 085672...............  Hydrochlorothiazide    ABC Holding Corp.
                             Tablets, 50 mg.
ANDA 085756...............  Cam-Metrazine          Camall Co., Inc.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 085766...............  Atropine Sulfate and   Private Formulations,
                             Diphenoxylate HCl      Inc.
                             Tablets, 0.025 mg/
                             2.5 mg.
ANDA 085882...............  Duvoid (bethanechol    Chartwell RX
                             chloride) Tablets,     Sciences, LLC, 77
                             50 mg.                 Brenner Dr.,
                                                    Congers, NY 10920.
ANDA 085888...............  Brompheniramine        Leiner Health
                             Maleate Tablets.       Products, Inc.
ANDA 085891...............  Meclizine HCl          Anabolic, Inc.
                             Tablets, 25 mg.
ANDA 085895...............  Secobarbital Sodium    Everylife.
                             Capsules, 100 mg.
ANDA 086008...............  Hydrocortisone and     Bioglan Laboratories,
                             Urea Cream, 1%/10%.    Ltd., 450 Hilltop
                                                    Rd., Riegelsville,
                                                    PA 18077.
ANDA 086077...............  Nitrofurazone          Ambix Laboratories,
                             Ointment, 0.2%.        Division of Organics
                                                    Corp. of America.
ANDA 086079...............  Hydrocortisone          Do.
                             Ointment, 1%.
ANDA 086080...............  Hydrocortisone Cream,   Do.
                             1%.
ANDA 086141...............  Tolbutamide Tablets,   Alra Laboratories,
                             500 mg.                Inc.
ANDA 086260...............  Ona-Mast (phentermine  MM Mast and Co.
                             HCl) Tablets, 8 mg.
ANDA 086262...............  Duvoid (bethanechol    Chartwell RX
                             chloride) Tablets,     Sciences, LLC.
                             10 mg.
ANDA 086263...............  Duvoid (bethanechol     Do.
                             chloride) Tablets,
                             25 mg.
ANDA 086271...............  Hydrocortisone Cream,  Ambix Laboratories,
                             2.5%.                  Division of Organics
                                                    Corp. of America.
ANDA 086272...............  Hydrocortisone          Do.
                             Ointment, 2.5%.
ANDA 086498...............  Amitriptyline HCl      Alra Laboratories,
                             Tablets, 10 mg.        Inc.
ANDA 086499...............  Amitriptyline HCl       Do.
                             Tablets, 50 mg.
ANDA 086500...............  Amitriptyline HCl       Do.
                             Tablets, 150 mg.
ANDA 086501...............  Amitriptyline HCl       Do.
                             Tablets, 100 mg.
ANDA 086502...............  Amitriptyline HCl       Do.
                             Tablets, 25 mg.
ANDA 086503...............  Amitriptyline HCl       Do.
                             Tablets, 75 mg.
ANDA 086511...............  Ona-Mast (phentermine  MM Mast and Co.
                             HCl) Capsules, 30 mg.
ANDA 086516...............  Ona-Mast (phentermine   Do.
                             HCl) Capsules, 30 mg.
ANDA 086550...............  X-Trozine              Shire Richwood, Inc.,
                             (phendimetrazine       7900 Tanners Gate
                             tartrate) Tablets,     Dr., Suite 200,
                             35 mg.                 Florence, KY 41042.
ANDA 086551...............  X-Trozine               Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 086552...............  X-Trozine               Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 086553...............  X-Trozine               Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 086554...............  X-Trozine               Do.
                             (phendimetrazine
                             tartrate) Tablets,
                             35 mg.
ANDA 086735...............  Phentermine HCl        Camall Co., Inc.
                             Capsules, 15 mg.
ANDA 086748...............  Theophylline Elixir,   Wockhardt EU
                             80 mg/15 mL.           Operations (Swiss)
                                                    AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
ANDA 086766...............  Nitrofurazone          Wendt Laboratories,
                             Ointment, 0.2%.        Inc.
ANDA 087081...............  Nitrofurazone Topical   Do.
                             Solution, 0.2%.
ANDA 087226...............  Phentermine HCl        Camall Co., Inc.
                             Capsules, 30 mg.
ANDA 087371...............  X-Trozine L.A.         Shire Richwood, Inc.
                             (phendimetrazine
                             tartrate) Extended-
                             Release Capsules,
                             105 mg.
ANDA 087392...............  Aminophylline          Pharma Serve, Inc.,
                             Injection, 25 mg/mL.   Subsidiary of
                                                    Torigian
                                                    Laboratories, 218-20
                                                    98th Ave., Queens
                                                    Village, NY 11429.
ANDA 087394...............  X-Trozine              Shire Richwood, Inc.
                             (phendimetrazine
                             tartrate) Capsules,
                             35 mg.
ANDA 087442...............  Neosar                 Bedford Laboratories,
                             (cyclophosphamide)     Division of Ben
                             for Injection, 100     Venue Laboratories,
                             mg/vial, 200 mg/       Inc., 300 Northfield
                             vial, 500 mg/vial, 1   Rd., Bedford, OH
                             g/vial, and 2 g/vial.  44146.
ANDA 087487...............  Melfiat-105            Numark Laboratories,
                             (phendimetrazine       Inc., 75 Mayfield
                             tartrate) Extended-    Ave., Edison, NJ
                             Release Capsules,      08837.
                             105 mg.
ANDA 087636...............  Tropicamide            Miza Pharmaceuticals
                             Ophthalmic Solution,   USA, Inc., c/o
                             0.5%.                  Optopics
                                                    Laboratories.
ANDA 087637...............  Tropicamide             Do.
                             Ophthalmic Solution,
                             1%.
ANDA 087681...............  Paracaine              Optopics Laboratories
                             (proparacaine HCl)     Corp.
                             Ophthalmic Solution,
                             0.5%.
ANDA 087764...............  Oby-Trim (phentermine  Shire Richwood, Inc.
                             HCl) Capsules, 30 mg.
ANDA 087932...............  Triamcinolone          Ambix Laboratories,
                             Acetonide Cream,       Division of Organics
                             0.025%.                Corp. of America.
ANDA 088786...............  Sodium Polystyrene     Wockhardt EU
                             Sulfonate USP          Operations (Swiss)
                             Powder, 453.6 g/       AG, c/o Morton Grove
                             bottle.                Pharmaceuticals,
                                                    Inc.

[[Page 1167]]

 
ANDA 088897...............  Promethazine VC Plain   Do.
                             (phenylephrine HCl
                             and promethazine
                             HCl) Syrup, 5 mg/5
                             mL and 6.25 mg/5 mL.
ANDA 089141...............  Aerolate               Fleming and Co.
                             (theophylline) Oral    Pharmaceuticals,
                             Solution, 150 mg/15    Inc.
                             mL.
ANDA 089417...............  Methocarbamol Tablets  American
                             USP, 500 mg.           Therapeutics, Inc.
ANDA 089418...............  Methocarbamol Tablets   Do.
                             USP, 750 mg.
ANDA 089478...............  Acetaminophen and       Do.
                             Codeine Phosphate
                             Tablets USP, 300 mg/
                             15 mg.
ANDA 089479...............  Acetaminophen and       Do.
                             Codeine Phosphate
                             Tablets USP, 300 mg/
                             30 mg.
ANDA 089480...............  Acetaminophen and       Do.
                             Codeine Phosphate
                             Tablets USP, 300 mg/
                             60 mg.
ANDA 089514...............  Trihexyphenidyl HCl    Pharmaceutical
                             Elixir, 2 mg/5 mL.     Ventures, Ltd., P.O.
                                                    Box D3700, Pomona,
                                                    NY 10970.
ANDA 089726...............  Prednisone Oral        Wockhardt EU
                             Solution, 5 mg/5 mL.   Operations (Swiss)
                                                    AG, c/o Morton Grove
                                                    Pharmaceuticals,
                                                    Inc.
ANDA 204472...............  Fludeoxyglucose F-18   MIPS Cyclotron and
                             Injection USP, 20-     Radiochemistry
                             300 mCi/mL.            Facility, 1201 Welch
                                                    Rd., Rm. PS049,
                                                    Stanford, CA 94305.
ANDA 204517...............  Sodium Fluoride F-18    Do.
                             Injection, 10-200
                             mCi/mL.
ANDA 204535...............  Ammonia N-13            Do.
                             Injection USP, 3.75-
                             37.5 mCi/mL.
------------------------------------------------------------------------

    Therefore, under Sec. Sec.  314.150(b)(1) and 314.200 (21 CFR 
314.150(b)(1) and 314.200), notice is given to the holders of the 
approved ANDAs listed in the table and to all other interested persons 
that the Director of CDER proposes to issue an order under section 
505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 355(e)) withdrawing approval of the ANDAs and all amendments and 
supplements to them on the grounds that the ANDA holders have failed to 
submit reports required under Sec. Sec.  314.81 and 314.98.
    In accordance with section 505 of the FD&C Act and part 314 (21 CFR 
part 314), the ANDA holders are hereby provided an opportunity for a 
hearing to show why the applications listed previously should not be 
withdrawn and an opportunity to raise, for an administrative 
determination, all issues relating to the legal status of the drug 
products covered by these ANDAs.
    An ANDA holder who decides to seek a hearing must file the 
following: (1) A written notice of participation and request for a 
hearing (see DATES and ADDRESSES) and (2) the data, information, and 
analyses relied on to demonstrate that there is a genuine and 
substantial issue of fact that requires a hearing (see DATES and 
ADDRESSES). Any other interested person may also submit comments on 
this notice. The procedures and requirements governing this notice of 
opportunity for a hearing, the notice of participation and request for 
a hearing; the information and analyses to justify a hearing, other 
comments, and a grant or denial of a hearing are contained in Sec.  
314.200 and in 21 CFR part 12.
    The failure of an ANDA holder to file a timely written notice of 
participation and request for a hearing, as required by Sec.  314.200, 
constitutes an election by that ANDA holder not to avail itself of the 
opportunity for a hearing concerning CDER's proposal to withdraw 
approval of the ANDAs and constitutes a waiver of any contentions 
concerning the legal status of the drug products. FDA will then 
withdraw approval of the ANDAs, and the drug products may not 
thereafter be lawfully introduced or delivered for introduction into 
interstate commerce. Any new drug product introduced or delivered for 
introduction into interstate commerce without an approved ANDA is 
subject to regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or 
denials but must present specific facts showing that there is a genuine 
and substantial issue of fact that requires a hearing. If a request for 
a hearing is not complete or is not supported, the Commissioner of Food 
and Drugs will enter summary judgment against the person who requests 
the hearing, making findings and conclusions, and denying a hearing.
    All submissions under this notice of opportunity for a hearing must 
be filed in four copies. Except for data and information prohibited 
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the 
submissions may be seen at the Dockets Management Staff (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at https://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and 
under authority delegated to the Director of CDER by the Commissioner 
of Food and Drugs.

    Dated: January 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00120 Filed 1-8-20; 8:45 am]
 BILLING CODE 4164-01-P


