Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction

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Published

August 4, 2025

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 15, 2025.

Full Text

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<title>Federal Register, Volume 90 Issue 147 (Monday, August 4, 2025)</title>
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[Federal Register Volume 90, Number 147 (Monday, August 4, 2025)]
[Notices]
[Pages 36444-36445]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14682]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-5964]


Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 
23 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 January 15, 2025.

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#81cce0f3f5e9e0afcfe6f4f8e4efc1e7e5e0afe9e9f2afe6eef7"><span class="__cf_email__" data-cfemail="efa28e9d9b878ec1a1889a968a81af898b8ec187879cc1888099">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: The document announced the withdrawal of 
approval of 23 abbreviated new drug applications (ANDAs) from multiple 
applicants, withdrawn as of February 14, 2025. The document erroneously 
included four previously withdrawn ANDAs; ANDA 079075 for Fentanyl 
Citrate (fentanyl citrate) tablet, Equivalent to (EQ) 0.1 milligrams 
(mg) base, EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 
mg base, held by Watson Laboratories, Inc. (an indirect, wholly owned 
subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Parkway, 
Bldg. A, Parsippany, NJ 07054; ANDA 206155 for Olanzapine (olanzapine) 
tablet, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg, held by RegCon 
Solutions, LLC, U.S. Agent for Indoco Remedies Ltd., 9920 Pacific 
Heights Blvd., Suite 250, San Diego, CA 92121; ANDA 206204 for 
Piperacillin and Tazobactam (piperacillin and tazobactam) injectable, 
EQ 12 grams (g) base/vial and EQ 1.5 g base/vial, held by Fresenius 
Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047; and ANDA 
209708 for Mivacurium Chloride (mivacurium chloride) solution, EQ 10 mg 
base/5 milliliters (mL) (EQ 2 mg base/mL) and EQ 20 mg base/10 mL (EQ 2 
mg base/mL), held by Woodward Pharma Services, LLC, 47220 Cartier Dr., 
Suite A, Wixom, MI 48393. This notice corrects that error. Because 
ANDAs 079075, 206155, 206204, and 209708 were withdrawn previously in 
the September 19, 2024 Federal Register notice titled ``Allergan, Inc., 
et al.; Withdrawal of Approval of Nine Abbreviated New Drug

[[Page 36445]]

Applications,'' those ANDA withdrawals still have an effective date of 
October 21, 2024.

Correction

    In the Federal Register of Wednesday, January 15, 2025 (90 FR 
3876), appearing on page 3876, 3877 in FR Doc. 2025-00742, the 
following correction is made:
    On page 3876-3877, in the table, the entries for ANDAs 079075, 
206155, 206204, and 209708 are removed.

    Dated: July 30, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14682 Filed 8-1-25; 8:45 am]
BILLING CODE 4164-01-P


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