Watson Laboratories, Inc., et al.; Withdrawal of Approval of 36 Abbreviated New Drug Applications; Correction, 54450 [2021-21371]
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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
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18:38 Sep 30, 2021
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
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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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[FR Doc. 2021–21418 Filed 9–28–21; 4:15 pm]
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Jkt 256001
Food and Drug Administration
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.
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approval of the ANDA withdrawn.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of this ANDA not be withdrawn, the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
SUMMARY:
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
[Docket No. FDA–2019–N–3077]
Agency Information Collection
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Information To Understand Challenges
and Opportunities Encountered by
Compounding Outsourcing Facilities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
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including each proposed extension of an
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to allow 60 days for public comment in
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requests comments on the information
collection associated with FDA research
in obtaining information from
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SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Page 54450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
-----------------------------------------------------------------------
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, [email protected].
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
