
[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Notices]
[Pages 17163-17168]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0021]


Actavis Totowa LLC, et al.; Withdrawal of Approval of Abbreviated 
New Drug Applications for Prescription Pain Medications Containing More 
Than 325 Milligrams of Acetaminophen

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 108 abbreviated new drug applications (ANDAs) for prescription pain 
medications containing more than 325 milligrams (mg) of acetaminophen. 
The holders of these ANDAs have voluntarily requested that approval of 
these applications be withdrawn and have waived their opportunity for a 
hearing.

DATES: Effective March 27, 2014.

FOR FURTHER INFORMATION CONTACT: Rachel Turow, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-
796-5094.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 14, 2011 
(76 FR 2691), FDA announced its plans to reduce the maximum dosage unit 
strength of acetaminophen in prescription drug products. The notice

[[Page 17164]]

announced FDA's conclusion that, based on a reevaluation of the 
relative risks and benefits of prescription acetaminophen products, 
fixed-combination prescription drugs containing more than 325 mg of 
acetaminophen per dosage unit (tablet or capsule) do not provide a 
sufficient margin of safety to protect the public against the serious 
risk of acetaminophen-induced liver injury. Accordingly, we asked 
product sponsors to limit the maximum amount of acetaminophen per 
dosage unit to 325 mg and, for those products containing more than 325 
mg of acetaminophen per dosage unit, to submit requests that FDA 
withdraw approval of their applications under Sec.  314.150(d) (21 CFR 
314.150(d)). FDA asked that all such requests be made before January 
14, 2014. Table 1 lists the applications for which FDA has received 
such requests. The sponsors of the applications listed in table 1 have 
also waived their opportunity for a hearing.

     Table 1--Applications for Which Withdrawal of Approval Has Been
                                Requested
------------------------------------------------------------------------
     Application No.          Drug product(s)       Applicant or holder
------------------------------------------------------------------------
ANDA 040199.............  Acetaminophen and       Actavis Totowa LLC,
                           Oxycodone               200 Elmora Ave.,
                           Hydrochloride           Elizabeth, NJ 07207.
                           Capsules, 500 mg/5 mg.
ANDA 040748.............  Acetaminophen and       Amneal
                           Hydrocodone             Pharmaceuticals, 85
                           Bitartrate Tablets,     Adams Ave.,
                           500 mg/7.5 mg.          Hauppauge, NY 11788.
ANDA 040754.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 040757.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
ANDA 040769.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040789.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 500 mg/7.5
                           mg.
                          Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 650 mg/10 mg.
ANDA 040813.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/10 mg.
ANDA 040729.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
ANDA 040304.............  Acetaminophen and       Barr Laboratories
                           Oxycodone               Inc., 2 Quaker Rd.,
                           Hydrochloride           P.O. Box 2900,
                           Capsules, 500 mg/5 mg.  Pomona, NY 10956.
ANDA 040307.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/2.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg
                           Acetaminophen and
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 040308.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040309.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/10 mg.
ANDA 040701.............  Acetaminophen,          Boca Pharmacal LLC,
                           Caffeine, and           3550 Northwest 126th
                           Dihydrocodeine          Ave., Coral Springs,
                           Bitartrate Tablets,     FL 33065.
                           712.8 mg/60 mg/32 mg.
ANDA 090265.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
                          Acetaminophen and       Caraco Pharmaceutical
                           Hydrocodone             Laboratories, Ltd.,
                           Bitartrate Tablets,     270 Prospect Plains
                           500 mg/10 mg.           Rd., Cranbury, NJ
                                                   08512.
ANDA 090380.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           660 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 088898.............  Acetaminophen and       Central
                           Hydrocodone             Pharmaceuticals Inc.,
                           Bitartrate Capsules,    110-128 East 3rd St.,
                           500 mg/5 mg.            Seymour, IN 47274.
ANDA 090177.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 500 mg/7.5
                           mg.
                          Acetaminophen and       Coastal
                           Oxycodone               Pharmaceuticals, 1240
                           Hydrochloride           Sugg Pkwy.,
                           Tablets, 650 mg/10 mg.  Greenville, NC 27834.
ANDA 040289.............  Acetaminophen and       Duramed
                           Oxycodone Capsules,     Pharmaceuticals Inc.,
                           500 mg/5 mg.            Sub Barr Laboratories
                                                   Inc., 2 Quaker Rd.,
                                                   P.O. Box 2900,
                                                   Pomona, NY 10970-
                                                   0519.
ANDA 076202.............  Acetaminophen and       Gavis Pharmaceuticals,
                           Pentazocine             LLC, 400 Campus Dr.,
                           Hydrochloride           Somerset, NJ 08873.
                           Tablets, 650 mg/EQ 25
                           mg Base.
ANDA 089696.............  Acetaminophen and       Ivax Pharmaceuticals
                           Hydrocodone             Inc., 140 Legrand
                           Bitartrate Tablets,     Ave., Northvale, NJ
                           500 mg/5 mg.            07647.

[[Page 17165]]

 
ANDA 089907.............  ALLAY (Acetaminophen     Do.
                           and Hydrocodone
                           Bitartrate) Capsules,
                           500 mg/5 mg.
ANDA 088790.............  TYLOX (Acetaminophen    Janssen Research &
                           and Oxycodone           Development, LLC, 920
                           Hydrochloride)          U.S. Hwy. 202, P.O.
                           Capsules, 500 mg/5 mg.  Box 300, Raritan, NJ
                                                   08869.
ANDA 040084.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and       Mallinckrodt Chemical
                           Hydrocodone             Inc., 675 McDonnell
                           Bitartrate Tablets,     Blvd., Hazelwood, MO
                           660 mg/10 mg.           63042.
ANDA 040201.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/10 mg.
ANDA 040257.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Capsules, 500 mg/5 mg.
ANDA 087336.............  LORCET-HD                Do.
                           (Acetaminophen and
                           Hydrocodone
                           Bitartrate) Capsules,
                           500 mg/5 mg.
ANDA 088956.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 088991.............  BUCET (Acetaminophen     Do.
                           and Butalbital)
                           Capsules, 650 mg/50
                           mg.
ANDA 089006.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 089160.............  ANEXSIA (Acetaminophen   Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           500 mg/5 mg.
ANDA 089405.............  TENCON (Acetaminophen    Do.
                           and Butalbital)
                           Capsules, 650 mg/50
                           mg.
ANDA 089725.............  ANEXSIA 7.5/650          Do.
                           (Acetaminophen and
                           Hydrocodone
                           Bitartrate) Tablets,
                           650 mg/7.5 mg.
ANDA 040418.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Oral
                           Solution, 500 mg/15
                           mL;7.5 mg/15 mL.
ANDA 040468.............  ANEXSIA (Acetaminophen   Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           750 mg/10 mg.
ANDA 040508.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Oral
                           Solution, 500 mg/15
                           mL;10 mg/15 mL.
ANDA 040550.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 500 mg/7.5
                           mg.
                          Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 650 mg/10 mg.
ANDA 040085.............  ESGIC-PLUS              Mikart, Inc., 1750
                           (Acetaminophen,         Chattahoochee Ave.,
                           Butalbital, and         Atlanta, GA 30318.
                           Caffeine) Capsules,
                           500 mg/50 mg/40 mg.
ANDA 040496.............  Acetaminophen,           Do.
                           Butalbital, and
                           Caffeine Tablets, 750
                           mg/50 mg/40 mg.
ANDA 040676.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 500 mg/10 mg.
ANDA 040679.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 400 mg/2.5
                           mg.
ANDA 040687.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 400 mg/5 mg.
ANDA 040692.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 400 mg/10 mg.
ANDA 040698.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 400 mg/7.5
                           mg.
ANDA 040849.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/5 mg.
ANDA 081051.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Oral
                           Solution, 500 mg/15
                           mL; 7.5 mg/15 mL.
ANDA 081067.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 081223.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
ANDA 089008.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 089451.............  ESGIC-PLUS               Do.
                           (Acetaminophen,
                           Butalbital, and
                           Caffeine) Tablets,
                           500 mg/50 mg/40 mg.
ANDA 089689.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 089698.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/2.5 mg.

[[Page 17166]]

 
ANDA 089699.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
ANDA 089988.............  BUTAPAP (Acetaminophen   Do.
                           and Butalbital)
                           Tablets, 650 mg/50 mg.
ANDA 089231.............  Acetaminophen and        Do.
                           Codeine Phosphate
                           Tablets, 650 mg/30 mg.
ANDA 089271.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
ANDA 089363.............  Acetaminophen and        Do.
                           Codeine Phosphate
                           Tablets, 650 mg/60 mg.
ANDA 040109.............  Acetaminophen,           Do.
                           Caffeine, and
                           Dihydrocodeine
                           Bitartrate Capsules,
                           356.4 mg/30 mg/16 mg.
ANDA 040316.............  Acetaminophen,           Do.
                           Caffeine, and
                           Dihydrocodeine
                           Bitartrate Tablets,
                           712.8 mg/60 mg/32 mg.
ANDA 081068.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 081069.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 081070.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 089557.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Oral
                           Solution, 500 mg/15
                           mL;5 mg/15 mL.
ANDA 089697.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
ANDA 040883.............  Acetaminophen,          Mirror Pharmaceuticals
                           Butalbital, and         LLC, 140 New Dutch
                           Caffeine Tablets, 500   Lane, Fairfield, NJ
                           mg/50 mg/40 mg.         07004.
ANDA 040219.............  Acetaminophen and       Mutual Pharmaceutical
                           Oxycodone Capsules,     Co. Inc., 1100
                           500 mg/5 mg.            Orthodox St.,
                                                   Philadelphia, PA
                                                   19124.
ANDA 040236.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040240.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 040061.............  ROXILOX (Acetaminophen  Roxane Laboratories
                           and Oxycodone           Inc., 1809 Wilson
                           Hydrochloride)          Rd., Columbus, OH
                           Capsules, 500 mg/5 mg.  43228.
ANDA 089775.............  ROXICET 5/500            Do.
                           (Acetaminophen and
                           Oxycodone
                           Hydrochloride)
                           Tablets, 500 mg/5 mg.
ANDA 040100.............  LORTAB (Acetaminophen   UCB Inc., 1950 Lake
                           and Hydrocodone         Park Dr., Bldg. 2100,
                           Bitartrate) Tablets,    Smyrna, GA 30080.
                           500 mg/10 mg.
ANDA 087722.............  LORTAB (Acetaminophen    Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           500 mg/5 mg.
ANDA 087757.............  CO-GESIC                 Do.
                           (Acetaminophen and
                           Hydrocodone
                           Bitartrate) Tablets,
                           500 mg/5 mg.
ANDA 088831.............  PHRENILIN FORTE         Valeant
                           (Acetaminophen and      Pharmaceuticals North
                           Butalbital) Capsules,   America LLC, 700
                           650 mg/50 mg.           Route 202/206 North,
                                                   Bridgewater, NJ
                                                   08807.
ANDA 040106.............  Acetaminophen and       Vintage
                           Oxycodone               Pharmaceuticals, 150
                           Hydrochloride           Vintage Dr.,
                           Capsules, 500 mg/5 mg.  Huntsville, AL 35811.
ANDA 040143.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
ANDA 040144.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/2.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
ANDA 040155.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 040157.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040356.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/10 mg.
ANDA 040358.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           660 mg/10 mg.
ANDA 040513.............  Acetaminophen,           Do.
                           Butalbital, and
                           Caffeine Tablets, 500
                           mg/50 mg/40 mg.
ANDA 040520.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Oral
                           Solution, 500 mg/15
                           mL;7.5 mg/15 mL.
ANDA 089971.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
ANDA 089831.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.

[[Page 17167]]

 
ANDA 040280.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 040281.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040288.............  ZYDONE (Acetaminophen    Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           400 mg/5 mg.
                          ZYDONE (Acetaminophen    Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           400 mg/7.5 mg.
                          ZYDONE (Acetaminophen    Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           400 mg/10 mg.
ANDA 040303.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Capsules, 500 mg/5 mg.
ANDA 040341.............  PERCOCET                 Do.
                           (Acetaminophen and
                           Oxycodone
                           Hydrochloride)
                           Tablets, 500 mg/7.5
                           mg.
                          PERCOCET                 Do.
                           (Acetaminophen and
                           Oxycodone
                           Hydrochloride)
                           Tablets, 650 mg/10 mg.
ANDA 040371.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 500 mg/7.5
                           mg.
                          Acetaminophen and       Watson Laboratories,
                           Oxycodone               311 Bonnie Circle,
                           Hydrochloride           Corona, CA 92880.
                           Tablets, 650 mg/10 mg.
ANDA 040094.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           660 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/10 mg.
ANDA 040234.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Capsules, 500 mg/5 mg.
ANDA 040267.............  Acetaminophen,           Do.
                           Butalbital, and
                           Caffeine Tablets, 500
                           mg/50 mg/40 mg.
ANDA 081079.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/2.5 mg.
ANDA 081080.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
ANDA 081083.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040122.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040123.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/2.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
ANDA 089883.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
ANDA 040493.............  Acetaminophen and       Watson Laboratories
                           Hydrocodone             Inc.--Florida, 2945
                           Bitartrate Tablets,     West Corporate Lakes
                           500 mg/5 mg.            Blvd., Suite B,
                                                   Weston, FL 33331.
ANDA 040494.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040495.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           660 mg/10 mg.
ANDA 040441.............  CODRIX (Acetaminophen    Do.
                           and Codeine
                           Phosphate) Tablets,
                           500 mg/30 mg.
ANDA 040447.............  CODRIX (Acetaminophen    Do.
                           and Codeine
                           Phosphate) Tablets,
                           500 mg/15 mg.
ANDA 040488.............  CODRIX (Acetaminophen    Do.
                           and Codeine
                           Phosphate) Tablets,
                           500 mg/60 mg.
ANDA 040261.............  Acetaminophen,          West-Ward
                           Butalbital, and         Pharmaceutical Corp.,
                           Caffeine Capsules,      435 Industrial Way
                           500 mg/50 mg/40 mg.     West, Eatontown, NJ
                                                   07724.

[[Page 17168]]

 
ANDA 040336.............  Acetaminophen,           Do.
                           Butalbital, and
                           Caffeine Tablets, 500
                           mg/50 mg/40 mg.
ANDA 040688.............  Acetaminophen,          WraSer Pharmaceuticals
                           Caffeine, and           LLC, 121 Marketridge
                           Dihydrocodeine          Dr., Ridgeland, MS
                           Bitartrate Capsules,    39157.
                           356.4 mg/30 mg/16 mg.
------------------------------------------------------------------------

    Therefore, under Sec.  314.150(d), and under authority delegated to 
the Director, Center for Drug Evaluation and Research, by the 
Commissioner of Food and Drugs, approval of the applications for the 
drug products listed in table 1 of this document, and all amendments 
and supplements thereto, is withdrawn (see DATES). Distribution of 
these products in interstate commerce without an approved application 
is illegal and subject to regulatory action (see sections 505(a) and 
301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).
    The safety issue discussed in this document and the January 14, 
2011, Federal Register document is limited to products containing more 
than 325 mg of acetaminophen per dosage unit. Thus, the withdrawal of 
approval of products containing more than 325 mg of acetaminophen per 
dosage unit listed in table 1 does not change the approval status of 
any products with 325 mg or less of acetaminophen per dosage unit that 
were approved under the same application. In addition, the withdrawal 
of approval of products containing more than 325 mg of acetaminophen 
per dosage unit does not change the approval status of products with 
325 mg or less of acetaminophen per dosage unit that refer to or rely 
on the withdrawn products. For example, this withdrawal action will not 
affect the approval status of an ANDA for a product that contains 325 
mg or less per dosage unit that references a product listed in table 1, 
but for which FDA approved a suitability petition for a lower strength 
under section 505(j)(2)(C) of the FD&C Act and Sec.  314.93 (21 CFR 
314.93)).

    Dated: March 24, 2014.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2014-06801 Filed 3-26-14; 8:45 am]
BILLING CODE 4160-01-P


