82 FR 32838 - 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 82, Issue 136 (July 18, 2017)

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 inadvertently announced withdrawal of approval for the following two ANDAs: ANDA 074123 for Pindolol Tablets, held by G&W Laboratories, Inc., 111 Coolidge St., South Plainfield, NJ 07080; and ANDA 080828 for Hydrocortisone Acetate Ophthalmic Ointment USP, held by Fera Pharmaceuticals LLC, 134 Birch Hill Rd., Locust Valley, NY 11560. FDA confirms that the approval of ANDAs 074123 and 080828 is still in effect.

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32838-32839]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-15003]


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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.

[[Page 32839]]


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 
inadvertently announced withdrawal of approval for the following two 
ANDAs: ANDA 074123 for Pindolol Tablets, held by G&W Laboratories, 
Inc., 111 Coolidge St., South Plainfield, NJ 07080; and ANDA 080828 for 
Hydrocortisone Acetate Ophthalmic Ointment USP, held by Fera 
Pharmaceuticals LLC, 134 Birch Hill Rd., Locust Valley, NY 11560. FDA 
confirms that the approval of ANDAs 074123 and 080828 is still in 
effect.

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 
corrections are made:
    1. On page 68429, in table 1, the entry for ANDA 074123 is removed.
    2. On page 68431, in table 1, the entry for ANDA 080828 is removed.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15003 Filed 7-17-17; 8:45 am]
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