Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications; Correction

---
identifier: "/us/fr/2023-11990"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2023-11990"
section_name: "Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications; Correction"
positive_law: false
currency: "2023-06-06"
last_updated: "2023-06-06"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2023-11990"
document_type: "notice"
publication_date: "2023-06-06"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "88 FR 37071"
fr_volume: 88
docket_ids:
  - "Docket No. FDA-2013-N-0845"
fr_action: "Notice; correction."
---


#  Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 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 July 19, 2013. The document announced the withdrawal of approval of 52 new drug applications (NDAs) and 77 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of August 19, 2013. The document erroneously included the withdrawal of ANDA 075328 for Pemoline tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811. This notice 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 Friday, July 19, 2013 (78 FR 43210), appearing on page 43213 in FR Doc. 2013-17324, the following correction is made:

On page 43213, in the table, the entry for ANDA 075328 is removed.

In a separate notice published in this issue of the *Federal Register* , FDA is withdrawing the approval of ANDA 075328 under 21 CFR 314.150(d).

Dated: May 31, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.