88 FR 242 pgs. 87787-87788 - Apothecon, et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction

Type: NOTICEVolume: 88Number: 242Pages: 87787 - 87788
Docket number: [Docket No. FDA-2009-N-0026]
FR document: [FR Doc. 2023-27859 Filed 12-18-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version
Pages: 87787, 87788

[top] page 87787

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:


[top] 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of approval of 103 new drug applications and 35 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 13, 2009.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, 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]

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