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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 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.

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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.

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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.

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Dated: September 30, 2011.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

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[FR Doc. 2011-26967 Filed 10-18-11; 8:45 am]

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