Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 4, 2005 (70 FR 10651). The document announced the withdrawal of approval of 76 new drug applications (NDAs) and 60 abbreviated new drug applications (ANDAs). The document inadvertently withdrew approval of ANDA 76-214 for Sotalol Hydrochloride Tablets, 80 milligrams (mg), 120 mg, and 160 mg, held by TorPharm, c/o Apotex Corp., 616 Heathrow Dr., Lincolnshire, IL 60069. FDA confirms that approval of ANDA 76-214 is still in effect.
April 4, 2005.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.End Further Info End Preamble Start Supplemental Information
In FR Doc. 05-4158, appearing on page 10651 in the Federal Register of Friday, March 4, 2005, the following correction is made:
1. On page 10656, in the table, the entry for ANDA 76-214 is removed.Start Signature
Dated: April 14, 2005.
Steven Galson, Acting Director.
Center for Drug Evaluation and Research.
[FR Doc. 05-8049 Filed 4-21-05; 8:45 am]
BILLING CODE 4160-01-S