Document ID: FDA-2023-N-2079-0002
Agency: fda
Document Type: Notice
Title: Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New
Drug Applications; Correction
Posted Date: 2023-09-25T04:00Z

[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Page 65691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20742]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2079]

Hospira, Inc., et al.; Withdrawal of Approval of Eight 
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 
entitled ``Hospira, Inc., et al.; Withdrawal of Approval of Eight 
Abbreviated New Drug Applications'' that appeared in the Federal 
Register of June 2, 2023. The document announced the withdrawal of 
approval (as of July 3, 2023) of eight abbreviated new drug 
applications (ANDAs) from multiple applicants. The document indicated 
that FDA was withdrawing approval of ANDA 077029, Calcipotriene 
Solution, 0.005% after receiving a withdrawal request from Tolmar, 
Inc., 701 Centre Ave., Fort Collins, CO 80526. Before FDA withdrew the 
approval of this ANDA, Tolmar, Inc. informed FDA that it did not want 
the approval of the ANDA withdrawn. Because Tolmar, Inc. timely 
requested that approval of ANDA 077029 not be withdrawn, the approval 
is still in effect. This document corrects that error.

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, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 2, 
2023 (88 FR 36320), in FR Doc. 2023-11744, the following correction is 
made:
    On page 36321, in the table, the entry for ANDA 077029 is removed.

    Dated: September 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20742 Filed 9-22-23; 8:45 am]
BILLING CODE 4164-01-P