Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications; Correction
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Abstract
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approval of 52 new drug applications (NDAs) and 77 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of August 19, 2013.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.
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<title>Federal Register, Volume 88 Issue 108 (Tuesday, June 6, 2023)</title>
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[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Page 37071]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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applicants, withdrawn as of August 19, 2013.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, <a href="/cdn-cgi/l/email-protection#743f1d19161106180d5a38111c0612111810341210155a1c1c075a131b02"><span class="__cf_email__" data-cfemail="cb80a2a6a9aeb9a7b2e587aea3b9adaea7af8badafaae5a3a3b8e5aca4bd">[email protected]</span></a>.
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]
BILLING CODE 4164-01-P
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