Document ID: FDA-2019-N-0113-0002
Agency: fda
Document Type: Notice
Title: Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
Posted Date: 2019-09-16T04:00Z

[Federal Register Volume 84, Number 179 (Monday, September 16, 2019)]
[Notices]
[Page 48623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19920]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0113]

Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23 
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 February 5, 2019. The document 
announced the withdrawal of approval of 23 abbreviated new drug 
applications (ANDAs) from multiple applicants, effective March 7, 2019. 
The document erroneously included ANDA 077895 for Ursodiol Capsules 
USP, 300 milligrams, held by Impax Laboratories, LLC. This notice 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Jennifer Forde, Office of Regulatory 
Policy, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6228, Silver 
Spring, MD 20993, 301-348-3035.

SUPPLEMENTARY INFORMATION: 

Correction

    In the Federal Register of Tuesday, February 5, 2019 (84 FR 1745), 
in FR Doc. 2019-01129, the following correction is made:
    1. On page 1746, in the table, the entry for ANDA 077895 is 
removed.
    In a separate notice published in this issue of the Federal 
Register, FDA is withdrawing the approval of ANDA 077895 under 21 CFR 
314.150(d).

    Dated: September 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19920 Filed 9-13-19; 8:45 am]
 BILLING CODE 4164-01-P