Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction

Federal Register, Volume 83 Issue 30 (Tuesday, February 13, 2018)

Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)

Notices

Page 6200

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2018-02926

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2016-N-0002

Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 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 October 4, 2016 (81 FR 68427). The document announced the withdrawal of approval of 44 new drug applications and 158 abbreviated new drug applications (ANDAs) from multiple applicants, effective November 3, 2016. The document erroneously included abbreviated new drug application (ANDA) 075726 for Pemoline Tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Mallinkrodt Pharmaceuticals, LLC. This notice corrects that error.

FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-

796-3601.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, October 4, 2016, appearing on page 68427 in FR Doc. 2016-23893, the following correction is made:

1. On page 68430, in table 1, the entry for ANDA 075726 is removed.

In a separate notice published in this issue of the Federal Register, FDA is withdrawing the approval of ANDA 075726 under 21 CFR 314.150(d).

Dated: February 8, 2018.

Leslie Kux,

Associate Commissioner for Policy.

FR Doc. 2018-02926 Filed 2-12-18; 8:45 am

BILLING CODE 4164-01-P