E9-23170. 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 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.