Notices. Notice; correction
211 words·~1 min read·
/register/2011/10/19/2011-26967A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-P 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. 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]