Document ID: FDA-2018-N-0478-0002
Agency: fda
Document Type: Notice
Title: Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New
Drug Applications; Correction
Posted Date: 2018-06-07T04:00Z

[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26481-26482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12220]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0478]

Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 
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 February 23, 2018. The notice 
announced the voluntary withdrawal of approval of 24 abbreviated new 
drug applications (ANDAs) from multiple applicants, effective March 26, 
2018. The notice indicated that FDA was withdrawing approval of the 
following ANDA after receiving a withdrawal request from Sun 
Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, 
Inc. (Sun Pharmaceutical), 2 Independence Way, Princeton, NJ 08540: 
ANDA 077483, Benazepril Hydrochloride and Hydrochlorothiazide Tablets, 
5 milligrams (mg)/6.25 mg, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 
mg. Before withdrawal of this ANDA became effective, however, Sun

[[Page 26482]]

Pharmaceutical informed FDA that it did not want approval of the ANDA 
withdrawn. Because Sun Pharmaceutical timely requested that approval of 
this ANDA not be withdrawn, the approval of ANDA 077483 is still in 
effect.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, February 
23, 2018 (83 FR 8089), appearing on page 8089 in FR Doc. 2018-03700, 
the following correction is made:
    1. On page 8090, the entry for ANDA 077483 in the table is removed.

    Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12220 Filed 6-6-18; 8:45 am]
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