70 FR 77 pg. 20918 - Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications; Correction
Type: NOTICEVolume: 70Number: 77Page: 20918
Docket number: [Docket No. 2005N-0058]
FR document: [FR Doc. 05-8049 Filed 4-21-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0058]
Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 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 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.
EFFECTIVE DATE:
April 4, 2005.
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.
SUPPLEMENTARY 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.
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]
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