
[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6896-6901]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe09-59]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0026]


Apothecon et al.; Withdrawal of Approval of 103 New Drug
Applications and 35 Abbreviated New Drug Applications

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is withdrawing
approval of 103 new drug applications (NDAs) and 35 abbreviated new
drug applications (ANDAs) from multiple applicants. The holders of the
applications notified the agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.

DATES: Effective March 13, 2009.

FOR FURTHER INFORMATION CONTACT:  Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table in this document have informed FDA that these drug products
are no longer marketed and have requested that FDA withdraw approval of
the applications. The applicants have also, by their requests, waived
their opportunity for a hearing.

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    Application No.                     Drug                                       Applicant
----------------------------------------------------------------------------------------------------------------
NDA 7-335               Pronestyl (procainamide               Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box
                         hydrochloride (HCl)) Capsules and     4000, Princeton, NJ 08543-4000
                         Injection
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NDA 7-935               Phenergan (promethazine HCl) Tablets  Wyeth Pharmaceuticals, Inc., P.O. Box 8299,
                                                               Philadelphia, PA 19101-8299
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NDA 9-193               Cogentin (benztropine mesylate)       Merck & Co., Inc., Sunneytown Pike, P.O. Box 4,
                         Tablets                               BLA-20, West Point, PA 19486
----------------------------------------------------------------------------------------------------------------
NDA 9-986               Deltasone (prednisone) Tablets        Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East
                                                               42d St., New York, NY 10017
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NDA 10-374              Medihaler-Epi (epinephrine            3M Pharmaceuticals, 3M Center, Bldg. 0275-05-W-12,
                         bitartrate)                           St. Paul, MN 55144-1000
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NDA 10-375              Medihaler-ISO (isoproterenol)         Do.
----------------------------------------------------------------------------------------------------------------
NDA 10-598              Bendectin (doxylamine succinate and   Sanofi-Aventis, 300 Somerset Corporate Blvd.,
                         pyridoxine HCl) Tablets               Bridgewater, NJ 08807-0977
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[[Page 6897]]


NDA 10-796              Harmonyl (deserpidine) Tablets        Abbott Laboratories, 200 Abbott Park Rd., Abbott
                                                               Park, IL 60064-6154
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NDA 10-800              Tralgon (acetaminophen) Elixir        Bristol-Myers Squibb Co., P.O. Box 4000,
                                                               Princeton, NJ 08543-4000
----------------------------------------------------------------------------------------------------------------
NDA 10-927              Phosphotope (sodium phosphates        Bracco Diagnostics, P.O. Box 5225, Princeton, NJ
                         solution USP) Oral Solution           08543-5225
----------------------------------------------------------------------------------------------------------------
NDA 10-928              Aureotope (gold injection)            Do.
----------------------------------------------------------------------------------------------------------------
NDA 11-161              Aristocort (triamcinolone) Tablets    Astellas Pharma US, Inc., Three Parkway North,
                                                               Deerfield, IL 60015-2537
----------------------------------------------------------------------------------------------------------------
NDA 11-467              Trancopal (chlormezanone) Tablets     Sanofi-Aventis
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NDA 11-721              Neptazane (methazolamide) Tablets     Lederle Laboratories, c/o Wyeth Pharmaceuticals,
                                                               Inc., P.O. Box 8299, Philadelphia, PA 19101-8299
----------------------------------------------------------------------------------------------------------------
NDA 11-751              Prolixin (fluphenazine HCl)           Apothecon, c/o Bristol-Myers Squibb Co.
                         Injection and Tablets
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NDA 11-832              Vasodilan (isoxsuprine HCl)           Do.
----------------------------------------------------------------------------------------------------------------
NDA 12-097              Kenalog in Orabase (triamcinolone     Do.
                         acetonide dental paste USP)
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NDA 12-164              Naturetin (bendroflumethiazide USP),  Do.
                         2.5 milligrams (mg), 5 mg, and 10
                         mg
----------------------------------------------------------------------------------------------------------------
NDA 12-515              Kenacort (tramcinolone diacetate)     Bristol-Meyers Squibb Co.
                         Syrup
----------------------------------------------------------------------------------------------------------------
NDA 13-296              Duo-Medihaler (phenyleprine           3M Pharmaceuticals
                         bitartrate and isoproterenol HCl)
----------------------------------------------------------------------------------------------------------------
NDA 13-601              Mucomyst (acetylcysteine solution     Apothecon, c/o Bristol-Myers Squibb Co.
                         USP)
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NDA 14-715              Triavil (perphenazine and             New River Pharmaceuticals, Inc., 2200 Kraft Dr.,
                         amitriptyline HCl) Tablets            suite 2050, Blacksburg, VA 24060
----------------------------------------------------------------------------------------------------------------
NDA 15-419              Hipputope (iodohippurate sodium I-    Bracco Diagnostics
                         131 injection USP)
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NDA 16-033              Vontrol (diphenidol HCl) Tablets, 25  GlaxoSmithKline, Five Moore Dr., P.O. Box 13398,
                         mg                                    Research Triangle Park, NC 27709
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NDA 16-090              Rubratope-60 (cyanocobalamin CO-60)   Bracco Diagnostics
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NDA 16-224              Robengatope (rose bengal sodium I-    Do.
                         131 injection USP)
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NDA 16-727              Prolixin Decanoate (fluphenazine      Bristol-Myers Squibb Co.
                         decanoate) Injection
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NDA 16-783              Vascoray (iothalamate meglumine, 52%  Tyco Healthcare/Mallinckrodt Inc., P.O. Box 5840,
                         and iothalamate sodium, 26%           St. Louis, MO 63134-0840
                         injection)
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NDA 16-906              Technetope II (technetium Tc-99m      Bracco Diagnostics
                         sodium pertechnetate sterile
                         generator
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NDA 16-923              Tesuloid (technetium Tc-99m sulfur    Do.
                         colloid kit)
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NDA 16-929              FUDR (floxuridine) Injection, 500 mg/ Hospira, Inc., 275 North Field Dr., Lake Forest,
                         5 milliliters (mL)                    IL 60045-5046
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NDA 16-996              Hyperstat (diazoxide) Injection       Schering Corp., 2000 Galloping Hill Rd.,
                                                               Kenilworth, NJ 07033
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NDA 17-024              Strotope (strontium nitrate Sr-85)    Bracco Diagnostics
                         Injection
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NDA 17-045              Renotec (technetium Tc-99m            Do.
                         ferpenetate kit)
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NDA 17-047              Sethotope (selenomethionine Se-75)    Do.
                         Injection
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NDA 17-269              Chlormerodrin Hg-197 Injection        Do.
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NDA 17-339              Minitec (technetium Tc-99m sodium     Do.
                         pertechnetate generator)
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[[Page 6898]]


NDA 17-371              Pronestyl (procainamide HCl) Tablets  Apothecon, c/o Bristol-Myers Squibb Co.
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NDA 17-395              Intropin (dopamine HCl) Injection,    Hospira, Inc.
                         40 mg/mL, 80 mg/mL, and 160 mg/mL
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NDA 17-598              Septra (trimethoprim and              Monarch Pharmaceutcals, Inc., 501 5th St.,
                         sulfamethoxazole) Oral Suspension     Bristol, TN 37620
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NDA 17-685              Conray 325 (iothalamate sodium)       Mallinckrodt Inc., 675 McDonnell Blvd., P.O. Box
                                                               5840, St. Louis, MO 63134
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NDA 17-787              Radionuclide-Labeled (I-125)          Abbott Laboratories
                         Fibrinogen Sensor
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NDA 17-834              Albumotope-LS (albumin aggregated     Bracco Diagnostics
                         iodinated I-131-serum)
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NDA 17-902              Renovue-65 (iodamide meglumine)       Do.
                         Injection, 65%
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NDA 17-903              Renovue-Dip (iodamide meglumine)      Do.
                         Injection
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NDA 17-931              Iletin I (insulin pork)               Eli Lilly & Co., Lilly Corporate Center,
                                                               Indianapolis, IN 46285
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NDA 17-932              Protamine Zinc and Iletin I (insulin  Do.
                         suspension protamine zinc beef/
                         pork)
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NDA 17-935              Ultralente Iletin I (insulin zinc     Do.
                         suspension extended beef/pork)
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NDA 17-936              NPH Iletin I (insulin suspension      Do.
                         isophane beef/pork)
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NDA 17-943              Proloprin (trimethoprim) Tablets,     Monarch Pharmaceuticals, Inc.
                         100 mg and 200 mg
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NDA 17-970              Nolvadex (tamoxifen citrate) Tablets  AstraZeneca Pharmaceuticals LP, 1800 Concord Pike,
                                                               P.O. Box 8355, Wilmington, DE 19803-8355
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NDA 17-979              Heparin Sodium Injection USP          Abraxis Pharmaceutical Products, Riverway One,
                                                               6133 North River Rd., suite 500, Rosemont, IL
                                                               60018
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NDA 18-017              Blocadren (timolol maleate) Tablets   Merck & Co., Inc., UG2C-50, P.O. Box 1000, North
                                                               Wales, PA 19454-1099
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NDA 18-061              Timolide (timolol maleate and         Do.
                         hydrochorothiazide) Tablets, 10 mg/
                         25mg
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NDA 18-076              Cholovue (iodoxamate meglumine)       Bracco Diagnostics
                         Injection, 40.3%
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NDA 18-077              Cholovue (iodoxamate meglumine) for   Do.
                         Infusion
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NDA 18-116              Cyclocort (amcinonide) Cream, 0.1%    Astellas Pharma US, Inc.
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NDA 18-211              Ditropan (oxybutynin chloride)        Ortho-McNeil-Janssen Pharmaceuticals, Inc., 1000
                         Syrup, 5 mg                           U.S. Highway 202, P.O. Box 3000, Raritan, NJ
                                                               08869-0602
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NDA 18-344              Iletin II (insulin purified pork)     Eli Lilly & Co.
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NDA 18-345              NPH Iletin II (insulin suspension     Do.
                         isophane purified pork)
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NDA 18-346              Protamine, Zinc, and Iletin II        Do.
                         (insulin suspension protamine zinc
                         purified pork)
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NDA 18-347              Lente Iletin II (insulin zinc         Do.
                         suspension purified pork)
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NDA 18-354              Ortho-Novum 10/11-21 and 10/11-28     Ortho-McNeil Pharmaceutical, Inc., c/o Johnson &
                         (norethindrone and ethinyl            Johnson Pharmaceutical Research & Development,
                         estradiol) Tablets                    LLC, 920 Rt. 202 South, P.O. Box 300, Raritan, NJ
                                                               08869
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NDA 18-452              Septra (sulfamethoxazole and          Monarch Pharmaceuticals, Inc.
                         trimethorprim) Injection
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[[Page 6899]]


NDA 18-476              Protamine, Zinc, and Iletin II        Eli Lilly & Co.
                         (insulin suspension protamine zinc
                         purified beef)
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NDA 18-477              Lente Iletin II (insulin zinc         Do.
                         suspension purified beef)
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NDA 18-478              Regular Iletin II (insulin purified   Do.
                         beef)
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NDA 18-479              NPH Iletin II (insulin suspension     Do.
                         isophane purified beef)
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NDA 18-498              Cyclocort (amcinonide) Ointment,      Astellas Pharma US, Inc.
                         0.1%
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NDA 18-537              Tridil (nitroglycerin) Injection      Hospira, Inc.
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NDA 18-831              Tracrium (atracurium besylate)        Hospira, Inc.
                         Injection
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NDA 18-873              Mexitil (mexiletine HCl) Capsules,    Boehringer Ingelheim Pharmaceuticals, Inc., 900
                         150 mg, 200 mg, and 250 mg            Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-
                                                               0368
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NDA 18-922              Lodine (etodolac) Capsules and        Wyeth Pharmaceuticals, Inc.
                         Tablets
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NDA 19-085              Atrovent (ipratropium bromide)        Boehringer Ingelheim Pharmaceuticals, Inc.
                         Aerosol
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NDA 19-166              Regular Insulin (insulin zinc         Eli Lilly & Co.
                         suspension beef) Injection
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NDA 19-167              NPH Insulin Beef (insulin zinc        Do.
                         suspension beef)
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NDA 19-529              Humulin BR (insulin recombinant       Do.
                         human)
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NDA 19-729              Cyclocort (amcinonide) Lotion, 0.1%   Astellas Pharma US, Inc.
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NDA 19-816              Oruvail (ketoprofen) Extended-        Wyeth Pharmaceuticals, Inc.
                         Release Capsules
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NDA 19-890              Stadol (butorphanol tartrate) Nasal   Bristol-Myers Squibb Co.
                         Spray
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NDA 19-965              Novolin L (insulin zinc suspension    Novo Nordisk, Inc., 100 College Road West,
                         recombinant human)                    Princeton, NJ 08540
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NDA 20-152              Serzone (nefazodone HCl) Tablets      Bristol-Myers Squibb Co.
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NDA 20-219              Livostin (levocabastine HCl)          Novartis Pharmaceuticals Corp., One Health Plaza,
                         Ophthalmic Suspension, 0.05%          East Hanover, NJ 07936-1080
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NDA 20-225              Indur (isosorbide mononitrate)        Schering Corp.
                         Extended-Release Tablets, 30 mg, 60
                         mg, and 120 mg
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NDA 20-326              Neutrexin (trimetrexate glucuronate)  MedImmune Oncology, Inc., One MedImmune Way,
                         Injection, 25 mg and 200 mg vials     Gaithersburg, MD 20878
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NDA 20-377              Cordarone (amiodarone HCl),           Wyeth Pharmaceuticals, Inc.
                         Injection, 50 mg/mL
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NDA 20-429              Orudis KT (ketoprofen) Tablets, 12.5  Wyeth Consumer Healthcare, Five Giralda Farms,
                         mg                                    Madison, NJ 07940
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NDA 20-584              Lodine XL (etodolac) Extended-        Wyeth Pharmaceuticals, Inc.
                         Release Tablets
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NDA 20-698              MiraLax (polyethylene glycol 3350)    Braintree Laboratories, Inc., 60 Columbian Street
                         Powder for Solution                   West, P.O. Box 850929, Braintree, MA 02185-0929
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NDA 20-784              Nasacort HFA (triamcinolone           Sanofi-Aventis
                         acetonide) Nasal Spray
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NDA 20-974              Prozac (fluoxetine HCl) Tablets       Eli Lilly & Co.
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NDA 21-028              Velosulin BR (insulin recombinant     Novo Nordisk, Inc.
                         injection)
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NDA 21-369              Codeprex (codeine polistirex and      UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080
                         chlorpheniramine polistirex)
                         Extended-Release Suspension
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NDA 21-387              Pravigard Pak (copackaged)            Bristol-Meyers Squibb Co.
                         (pravastatin sodium and aspirin)
                         Tablets
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[[Page 6900]]


ANDA 40-305             Meperidien HCl Injection USP, 10 mg/  Hospira, Inc.
                         mL
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NDA 50-155              Chloromycetin Sodium Succinate        Parkedale Pharmaceuticals, Inc., c/o King
                         (chloramphenicol sodium succinate     Pharmaceuticals, Inc., 501 5th St., Bristol, TN
                         for injection USP)                    37620
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NDA 50-205              Chloromycetin (chloramphenicol)       Do.
                         Otitic Solution
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NDA 50-285              Mycifradin (neomycin sulfate) Oral    Pharmacia & Upjohn Co., c/o Pfizer, Inc.
                         Suspension
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NDA 50-339              Albamycin (novobiocin sodium)         Do.
                         Capsules
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NDA 50-435              Geocillin (carbenicillin indanyl      Pfizer, Inc., 235 East 42d St., New York, NY 10017
                         sodium) Tablets, 382 mg
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NDA 50-504              Mandol (cefamandole nafate)           Eli Lilly & Co.
                         Injection
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NDA 50-589              Cefizox (ceftizoxime sodium)          Astellas Pharma US, Inc.
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NDA 50-621              Suprax (cefixime) Tablets, 200 mg     Lederle Laboratories, c/o Wyeth Pharmaceuticals,
                         and 400 mg                            Inc.
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NDA 50-622              Suprax (cefixime) Powder for          Do.
                         Suspension
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ANDA 60-591             Chloromycetin (chloramphenicol        Parkedale Pharmaceuticals, Inc., c/o King
                         capsules USP), 50 mg, 100 mg, and     Pharmaceuticals, Inc.
                         250 mg
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ANDA 61-922             Vidarabine Monohydrate Micronized     Do.
                         Powder, Sterile
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ANDA 62-655             Tazidime (ceftazidime for injection   Eli Lilly & Co.
                         USP)
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ANDA 63-350             Amikacin Sulfate Injection USP, 50    Hospira, Inc.
                         mg base/mL and 250 mg base/mL
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ANDA 70-847             Metoclopramide Injection USP, 5 mg    Hospira, Inc.
                         base/mL
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ANDA 71-291             Metoclopramide Injection USP, 5 mg    Do.
                         base/mL
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ANDA 71-364             Acetylcysteine Solution USP           Do.
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ANDA 71-365             Acetylcysteine Solution USP           Do.
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ANDA 71-645             Droperidol Injection USP, 2.5 mg/mL   Do.
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ANDA 73-272             Albuterol Inhalation Aerosol          IVAX Pharmaceuticals Ireland, c/o IVAX
                                                               Pharmaceuticals, Inc., Two University Plaza,
                                                               suite 220, Hackensack, NJ 07601
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ANDA 74-966             Fluphenazine Decanoate Injection, 25  Hospira, Inc.
                         mg/mL
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ANDA 75-106             Diltiazem HCl Injection, 5 mg/mL      Do.
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ANDA 75-242             Labetalol HCL Injection, 5 mg/mL      Do.
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ANDA 75-342             Butorphanol Tartrate Injection USP,   Do.
                         1 mg/mL and 2mg/mL
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ANDA 75-396             Midazolam HCl Injection               Do.
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ANDA 75-484             Midazolam HCl Injection, 5 mg base/   Do.
                         mL
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ANDA 75-571             Enalaprilat Injection, 1.25 mg/mL     Do.
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ANDA 75-669             Famotidine Injection, 10 mg/mL        Do.
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ANDA 75-705             Famotidine Injection, 10 mg/mL        Do.
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ANDA 75-816             Calcitriol Injection                  Do.
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ANDA 75-830             Milrinone Lactate Injection, 1 mg     Do.
                         base/mL
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ANDA 75-108             Amiodarone HCl Injection, 50 mg/mL    Do.
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ANDA 76-233             Paclitaxel Injection                  Do.
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ANDA 76-473             Carboplatin for Injection USP         Do.
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[[Page 6901]]


ANDA 76-978             Ondansetron HCl and Dextrose          Do.
                         Injection
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ANDA 77-362             Amlodipine Besylate Tablets           King and Spalding, U.S. Agent for Genpharm Inc.,
                                                               1700 Pennsylvania Ave., NW., Washington, DC 20006-
                                                               4706
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ANDA 77-925             Meloxicam Tablets, 7.5 mg and 15 mg   Roxane Laboratories, Inc., 1809 Wilson Rd.,
                                                               Columbus, OH 43228
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ANDA 85-153             Alkergot (ergoloid mesylates)         Sandoz, Inc., 227-15 North Conduit Ave.,
                         Sublingual Tablets, 0.5 mg            Laurelton, NY 11413
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ANDA 85-916             Diethylpropion HCl Tablets, 25 mg     Do.
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ANDA 86-172             Meclizine HCl Tablets, 12.5 mg        Do.
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ANDA 86-174             Meclizine HCl Tablets, 25 mg          Do.
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ANDA 86-184             Sulfasalazine Tablets, 500 mg         Do.
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ANDA 87-417             Alkergot (ergoloid mesylates)         Do.
                         Sublingual Tablets, 1 mg
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ANDA 89-565             Vinblastine Sulfate Injection, 10 mg/ Hospira, Inc.
                         vial
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    Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the
Director, Center for Drug Evaluation and Research, by the Commissioner
of Food and Drugs, approval of the applications listed in the table in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective March 13, 2009.

    Dated: January 12, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E9-2901 Filed 2-10-09; 8:45 am]

BILLING CODE 4160-01-S
