Document ID: FDA-2013-N-0845-0002
Agency: fda
Document Type: Notice
Title: Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications; Correction
Posted Date: 2023-06-06T04:00Z

[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Page 37071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11990]

[[Page 37071]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0845]

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.

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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applicants, withdrawn as of August 19, 2013.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.
[FR Doc. 2023-11990 Filed 6-5-23; 8:45 am]
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