83 FR 26481 - Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 110 (June 7, 2018)

Page Range26481-26482
FR Document2018-12220

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of this ANDA became effective, however, Sun Pharmaceutical informed FDA that it did not want approval of the ANDA withdrawn. Because Sun Pharmaceutical timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 077483 is still in effect.

Federal Register, Volume 83 Issue 110 (Thursday, June 7, 2018)
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26481-26482]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12220]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4164-01-P


Current View
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; correction.
ContactTrang 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.
FR Citation83 FR 26481 

2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR