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Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications; Correction

89 Fed. Reg. 74968 (Sep. 13, 2024)

Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications; Correction

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Federal RegisterSep 13, 2024
89 Fed. Reg. 74968 (Sep. 13, 2024)
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    Department of Health and Human Services Food and Drug Administration
  • [Docket No. FDA-2024-N-2803]

    • 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 June 21, 2024. The document announced the withdrawal of approval of 20 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 22, 2024. The document indicated that FDA was withdrawing approval of the ANDA 076648 for nitrofurantoin (monohydrate/macrocrystals) capsules, 75 milligrams (mg) and 25 mg, held by Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520; and the ANDA 090723 for duloxetine hydrochloride capsules, delayed-release pellets, Equivalent to (EQ) 20 mg base, EQ 30 mg base, and EQ 60 mg base, held by Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., 150 Motor Pkwy., Suite 401, 4th Floor, Rm. 430, Hauppauge, NY 11788. Before FDA withdrew the approval of these ANDAs, Aurobindo Pharma USA Inc., and Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., informed FDA that they did not want the approval of the ANDAs withdrawn. Because Aurobindo Pharma USA Inc. and Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., timely requested that approval of their respective ANDAs not be withdrawn, the approvals are still in effect. This notice corrects these errors.

    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 Friday, June 21, 2024 (89 FR 52057), appearing on page 52058 in FR Doc. 2024-13660, the following correction is made:

    On page 52058, in the table, the entries for ANDA 076648 and ANDA 090723 are removed.

    Dated: September 10, 2024.

    Lauren K. Roth,

    Associate Commissioner for Policy.

    [FR Doc. 2024-20873 Filed 9-12-24; 8:45 am]

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