Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 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 September 24, 2025 (90 FR 183), appearing on page 45942 in FR Doc. 2025-18453. The document announced the withdrawal of approval of 72 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of October 23, 2025. The document indicated that FDA was withdrawing approval of the ANDA 070631 for valproic acid, capsule, 250 milligrams, held by Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369. Before FDA withdrew the approval of this ANDA, Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369, informed FDA that they did not want the approval of the ANDA withdrawn. Because Upsher-Smith Laboratories, LLC, timely requested that approval of the ANDA not be withdrawn, the approval is still in effect. This notice corrects this error.
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<title>Federal Register, Volume 91 Issue 58 (Thursday, March 26, 2026)</title>
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[Federal Register Volume 91, Number 58 (Thursday, March 26, 2026)]
[Notices]
[Page 14703]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05913]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA-2025-N-3346]
Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72
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 September 24, 2025 (90 FR
183), appearing on page 45942 in FR Doc. 2025-18453. The document
announced the withdrawal of approval of 72 abbreviated new drug
applications (ANDAs) from multiple applicants, withdrawn as of October
23, 2025. The document indicated that FDA was withdrawing approval of
the ANDA 070631 for valproic acid, capsule, 250 milligrams, held by
Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN
55369. Before FDA withdrew the approval of this ANDA, Upsher-Smith
Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369, informed
FDA that they did not want the approval of the ANDA withdrawn. Because
Upsher-Smith Laboratories, LLC, timely requested that approval of the
ANDA not be withdrawn, the approval is still in effect. This notice
corrects this error.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-
796-3471, <a href="/cdn-cgi/l/email-protection#f5b89487819d94dbbb92808c909bb5939194db9d9d86db929a83"><span class="__cf_email__" data-cfemail="4f022e3d3b272e6101283a362a210f292b2e6127273c61282039">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of Wednesday
September 24, 2025 (90 FR 183), appearing on page 45942 in FR Doc.
2025-18453, the following correction is made:
On page 45943, in the table, the entry for ANDA 070631 is removed.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-05913 Filed 3-25-26; 8:45 am]
BILLING CODE 4164-01-P
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