Watson Laboratories, Inc., et al.; Withdrawal of Approval of 36 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 of June 25, 2021. The document announced the withdrawal of approval of 36 abbreviated new drug applications (ANDAs) from multiple applicants as of July 26, 2021. The document indicated that FDA was withdrawing approval of the following ANDA, after receiving a withdrawal request from Yung Shin Pharmaceutical Ind. Co. Ltd., authorized U.S. agent, Carlsbad Technology, Inc./Simon Law, 5922 Farnsworth Ct., Suite 101, Carlsbad, CA 92008: ANDA 065152, Cephalexin Capsules, Equivalent to (EQ) 250 milligrams (mg) base and EQ 500 mg base. Before FDA withdrew the approval of this ANDA, Yung Shin Pharmaceutical Ind. Co. Ltd. informed FDA that it did not want the approval of the ANDA withdrawn. Because Yung Shin Pharmaceutical Ind. Co. Ltd. timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 065152 is still in effect.
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<title>Federal Register, Volume 86 Issue 188 (Friday, October 1, 2021)</title>
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[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Page 54450]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21371]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0492]
Watson Laboratories, Inc., et al.; Withdrawal of Approval of 36
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 of June 25, 2021. The document
announced the withdrawal of approval of 36 abbreviated new drug
applications (ANDAs) from multiple applicants as of July 26, 2021. The
document indicated that FDA was withdrawing approval of the following
ANDA, after receiving a withdrawal request from Yung Shin
Pharmaceutical Ind. Co. Ltd., authorized U.S. agent, Carlsbad
Technology, Inc./Simon Law, 5922 Farnsworth Ct., Suite 101, Carlsbad,
CA 92008: ANDA 065152, Cephalexin Capsules, Equivalent to (EQ) 250
milligrams (mg) base and EQ 500 mg base. Before FDA withdrew the
approval of this ANDA, Yung Shin Pharmaceutical Ind. Co. Ltd. informed
FDA that it did not want the approval of the ANDA withdrawn. Because
Yung Shin Pharmaceutical Ind. Co. Ltd. timely requested that approval
of this ANDA not be withdrawn, the approval of ANDA 065152 is still in
effect.
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, 240-
402-6980, <a href="/cdn-cgi/l/email-protection#a5e8c4d7d1cdc48bebc2d0dcc0cbe5c3c1c48bcdcdd68bc2cad3"><span class="__cf_email__" data-cfemail="6a270b181e020b44240d1f130f042a0c0e0b44020219440d051c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 25,
2021 (86 FR 33718), FR Doc. 2021-13593, the following correction is
made:
On page 33718, in the table, the entry for ANDA 065152 is removed.
Dated: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21371 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P
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