Notices. Notice; correction
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/register/2023/12/19/2023-27859·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P 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. SUMMARY: The Food and Drug Administration
(FDA)is correcting a notice that appeared in the **Federal Register** on February 11, 2009. The document announced the withdrawal of approval of 103 new drug applications and 35 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 13, 2009. The document erroneously included ANDA 75-108. The correct ANDA is ANDA 76-108 for Amiodarone hydrochloride
(HCl)injection, 50 milligrams (mg)/milliliter (mL), held by Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045-5046. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-796-3137, *Kimberly.Lehrfeld@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: In the **Federal Register** of February 11, 2009 (74 FR 6896), appearing on page 6900 in FR Doc. E9-2901, the following correction is made: On page 6900, in the table, in the first column, the Application No. for the entry for Amiodarone HCL Injection, 50 mg/mL held by Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045-5046 is corrected to ANDA 76-108. Dated: December 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-27859 Filed 12-18-23; 8:45 am]