Document ID: FDA-2011-N-0021-0007
Agency: fda
Document Type: Notice
Title: Actavis Totowa LLC, et al.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen; Correction
Posted Date: 2014-05-01T04:00Z

[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Page 24734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09898]

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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; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of March 27, 2014 (79 FR 17163). 
The document withdrew approval of 108 abbreviated new drug applications 
(ANDAs) for prescription pain medications containing more than 325 
milligrams (mg) of acetaminophen per dosage unit from multiple 
applicants, effective March 27, 2014. The document failed to withdraw 
approval of ANDAs 040825, 040822, and 040824, held by Ranbaxy 
Laboratories Inc. and Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 
08540, and ANDA 040182, held by Pharmaceutical Associates, Inc., 201 
Delaware St., Greenville, SC 29605. The holders of these applications 
have voluntarily requested that approval of these applications be 
withdrawn and have waived their opportunity for a hearing. FDA confirms 
the withdrawal of approval of ANDAs 040825, 040824, 040822, and 040182.

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 FR Doc. 2014-06801, appearing on page 
17163, in the Federal Register of Thursday, March 27, 2014, the 
following correction is made:
    On page 17166, in table 1, the following entries are added in 
alphabetical order by Applicant:

------------------------------------------------------------------------
   Application No.         Drug product(s)         Applicant or holder
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ANDA 040182.........  Acetaminophen and         Pharmaceutical
                       Hydrocodone Bitartrate    Associates, Inc., 201
                       Oral Solution, 7.5 mg/    Delaware St.,
                       500 mg/15 milliters       Greenville, SC 29605.
                       (mL), available in 473
                       mL, 118 mL, 15 mL, and
                       10 mL.
ANDA 040825.........  Acetaminophen and         Ranbaxy Laboratories
                       Hydrocodone Bitartrate    Inc., 600 College Rd.
                       Tablets, 500 mg/5 mg.     East, Princeton, NJ
                                                 08540.
ANDA 040822.........  Acetaminophen and         Do.
                       Hydrocodone Bitartrate
                       Tablets, 750 mg/7.5 mg.
ANDA 040824.........  Acetaminophen and         Ranbaxy Inc., 600
                       Hydrocodone Bitartrate    College Rd. East,
                       Tablets, 500 mg/10 mg.    Princeton, NJ 08540.
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    Dated: April 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09898 Filed 4-30-14; 8:45 am]
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