Apothecon, et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction

---
identifier: "/us/fr/2023-27859"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Apothecon, et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2023-27859"
section_name: "Apothecon, et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction"
positive_law: false
currency: "2023-12-19"
last_updated: "2023-12-19"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2023-27859"
document_type: "notice"
publication_date: "2023-12-19"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "88 FR 87787"
fr_volume: 88
docket_ids:
  - "Docket No. FDA-2009-N-0026"
fr_action: "Notice; correction."
---


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of approval of 103 new drug applications and 35 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 13, 2009.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