[Federal Register: April 22, 2005 (Volume 70, Number 77)]
[Page 20918]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 

    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]