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

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 via the Government Publishing Office www.gpo.gov

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Pharmaceutical informed FDA that it did not want approval of the ANDA withdrawn. Because Sun Pharmaceutical timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 077483 is still in effect.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

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT