Document ID: FDA-2009-N-0026-0002
Agency: fda
Document Type: Notice
Title: Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated NewDrug Applications; Correction
Posted Date: 2009-09-25T04:00Z

[Federal Register: September 25, 2009 (Volume 74, Number 185)]
[Notices]               
[Page 48993]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25se09-101]                         

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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.

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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 announced the withdrawal of approval of 103 new 
drug applications (NDAs) and 35 abbreviated new drug applications 
(ANDAs). The document published with an error in the identification of 
the ANDA for Amiodarone Hydrochloride Injection, 50 milligrams/
milliliter, held by Hospira, Inc. This document corrects that error.

DATES:  Effective March 13, 2009.

FOR FURTHER INFORMATION CONTACT:  Florine P. 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:
    On page 6900, in the first column of the table, third item from the 
bottom of the page, the entry ``ANDA 75-108'' is corrected to read 
``ANDA 76-108''.

    Dated: September 9, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E9-23170 Filed 9-24-09; 8:45 am]

BILLING CODE 4160-01-S