Document ID: FDA-2020-N-1866-0002
Agency: fda
Document Type: Notice
Title: Wockhardt Ltd., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications; Correction
Posted Date: 2020-12-21T05:00Z

[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Page 83097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28081]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1866]

Wockhardt Ltd., et al.; Withdrawal of Approval of Nine 
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 
entitled ``Wockhardt Ltd., et al.; Withdrawal of Approval of Nine 
Abbreviated New Drug Applications'' that appeared in the Federal 
Register on October 9, 2020. The document announced the withdrawal of 
approval (as of November 9, 2020) of nine abbreviated new drug 
applications (ANDAs) from multiple applicants. The document indicated 
that FDA was withdrawing approval of the following ANDA after receiving 
a withdrawal request from VistaPharm, Inc., 7265 Ulmerton Rd., Largo, 
FL 33771: ANDA 077788, Albuterol Sulfate Syrup, Equivalent to 2 
milligrams base/5 milliliters. Before FDA withdrew the approval of this 
ANDA, VistaPharm, Inc., informed FDA that it did not want the approval 
of the ANDA withdrawn. Because VistaPharm, Inc., timely requested that 
approval of this ANDA not be withdrawn, the approval of ANDA 077788 is 
still in effect.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, Martha.Nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 9, 2020 
(85 FR 64150), in FR Doc. 2020-22403, the following correction is made:
    On page 64150, in the table, the entry for ANDA 077788 is removed.

    Dated: December 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28081 Filed 12-18-20; 8:45 am]
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