Food and Drug Administration, HHS.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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.Start Signature
Dated: September 30, 2011.
Director, Center for Drug Evaluation and Research.
[FR Doc. 2011-26967 Filed 10-18-11; 8:45 am]
BILLING CODE 4160-01-P