83 FR 131 - Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 1 (January 2, 2018)

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 24, 2017. The document announced the withdrawal of approval of 54 abbreviated new drug applications (ANDAs) from two applicants, effective November 24, 2017. The notice inadvertently announced the withdrawal of approval for ANDA 087296 for Chlorthalidone Tablets USP, 25 milligrams, held by Watson Laboratories, Inc., a subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. FDA confirms that the approval of ANDA 087296 is still in effect.

[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Page 131]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-28253]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5715]


Watson Laboratories, Inc., and Barr Laboratories, Inc., 
Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval 
of 54 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 24, 2017. The document 
announced the withdrawal of approval of 54 abbreviated new drug 
applications (ANDAs) from two applicants, effective November 24, 2017. 
The notice inadvertently announced the withdrawal of approval for ANDA 
087296 for Chlorthalidone Tablets USP, 25 milligrams, held by Watson 
Laboratories, Inc., a subsidiary of Teva Pharmaceuticals USA, Inc., 425 
Privet Rd., Horsham, PA 19044. FDA confirms that the approval of ANDA 
087296 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 FR Doc. 2017-23046, appearing on page 
49214 in the Federal Register of Tuesday, October 24, 2017, the 
following correction is made:
    1. On page 49215, in table 1, the entry for ANDA 087296 is removed.

    Dated: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28253 Filed 12-29-17; 8:45 am]
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