This PDF is the current document as it appeared on Public Inspection on 07/17/2017 at 08:45 am.
Food and Drug Administration, HHS.Start Printed Page 32839
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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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.Start Signature
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]
BILLING CODE 4164-01-P