[Federal Register Volume 89, Number 178 (Friday, September 13, 2024)]
[Notices]
[Pages 74968-74969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20873]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2803]


Sandoz Inc., et al.; Withdrawal of Approval of 20 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 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applications (ANDAs) from multiple applicants, withdrawn as of July 22, 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withdrawn.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their respective ANDAs not be withdrawn, the approvals are still in 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, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 21, 
2024 (89 FR 52057), appearing on page

[[Page 74969]]

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]
BILLING CODE 4164-01-P