Document ID: FDA-2009-N-0026-0005
Agency: fda
Document Type: Notice
Title: Apothecon, et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction
Posted Date: 2023-12-19T05:00Z

[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87787-87788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27859]

-----------------------------------------------------------------------

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

[[Page 87788]]

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multiple applicants, withdrawn as of March 13, 2009.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, [email protected].

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]
BILLING CODE 4164-01-P