83 FR 6200 - Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

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.

[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Page 6200]
From the Federal Register Online  [www.thefederalregister.org]
[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