Document ID: FDA-2009-N-0026-0003
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications: Apothecon et al.; Correction
Posted Date: 2011-10-19T04:00Z

[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Notices]
[Page 64951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26967]

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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; 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 February 11, 2009 (74 FR 
6896). The document withdrew approval of 103 new drug applications 
(NDAs) and 35 abbreviated new drug applications (ANDAs) from multiple 
applicants. The document inadvertently withdrew approval of NDA 50-435 
for GEOCILLIN (carbenicillin indanyl sodium) Tablets held by Pfizer, 
Inc., 235 East 42d St., New York, NY 10017. FDA confirms that approval 
of NDA 50-435 is still in effect.

FOR FURTHER INFORMATION CONTACT: Florine 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: In FR Doc. E9-2901, appearing on page 6896, 
in the Federal Register of Wednesday, February 11, 2009, the following 
correction is made:
    1. On page 6900, in the table, the entry for NDA 50-435 is removed.

    Dated: September 30, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2011-26967 Filed 10-18-11; 8:45 am]
BILLING CODE 4160-01-P