Document ID: FDA-2011-N-0021-0008
Agency: fda
Document Type: Notice
Title: AbbVie Inc., et al.; Proposal To Withdraw Approval of Abbreviated
New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen; Opportunity for a
Hearing; Correction
Posted Date: 2014-05-01T04:00Z

[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Page 24735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09900]

[[Page 24735]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

AbbVie Inc., et al.; Proposal To Withdraw Approval of Abbreviated 
New Drug Applications for Prescription Pain Medications Containing More 
Than 325 Milligrams of Acetaminophen; Opportunity for a Hearing; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of March 27, 2014 (79 FR 17156). 
The document announced an opportunity to request a hearing on the 
Agency's proposal to withdraw approval of abbreviated new drug 
applications (ANDAs) from multiple sponsors. The document incorrectly 
stated that the approval of ANDAs 40825, 40822, and 40824, held by 
Ranbaxy Laboratories Inc. and Ranbaxy Inc., 600 College Rd. East, 
Princeton, NJ 08540, and ANDA 40182, held by Pharmaceutical Associates, 
Inc., 201 Delaware St., Greenville, SC 29605, had not been voluntarily 
withdrawn. FDA confirms that the approval of ANDAs 40825, 40824, 40822, 
and 40182 has been voluntarily withdrawn.

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. 2014-06802, appearing on page 
17156, in the Federal Register of Thursday, March 27, 2014, the 
following correction is made:
    On page 17157, in table 1, the entries for ANDAs 40825, 40824, 
40822, and 40182 are removed. The approval of these applications has 
been withdrawn under 21 CFR 314.150(d).

    Dated: April 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09900 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P