83 FR 1 pg. 131 - Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications; Correction
Type: NOTICEVolume: 83Number: 1Page: 131
Page: 131Docket number: [Docket No. FDA-2017-N-5715]
FR document: [FR Doc. 2017-28253 Filed 12-29-17; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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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