    [Federal Register Volume 91, Number 58 (Thursday, March 26, 2026)]
    [Notices]
    [Page 14703]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 2026-05913]

    -----------------------------------------------------------------------

    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.

    -----------------------------------------------------------------------

    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    applications (ANDAs) from multiple applicants, withdrawn as of October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    FDA that they did not want the approval of the ANDA withdrawn.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    ANDA not be withdrawn, the approval is still in effect.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, Martha.Nguyen@fda.hhs.gov.

    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