Document ID: FDA-2020-N-2306-0002
Agency: fda
Document Type: Notice
Title: TG United, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; Correction
Posted Date: 2021-04-01T04:00Z

[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Page 17165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06745]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2306]

TG United, Inc., et al.; Withdrawal of Approval of 27 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 
that appeared in the Federal Register of January 15, 2021. The document 
announced the withdrawal of approval of 27 abbreviated new drug 
applications (ANDAs) from multiple applicants as of February 16, 2021. 
The document indicated that FDA was withdrawing approval of the 
following three ANDAs after receiving a withdrawal request from Upsher-
Smith Laboratories, LLC., 6701 Evenstad Dr., Maple Grove, MN 55369: 
ANDA 084041, Chlordiazepoxide Hydrochloride (HCl) Capsules, 10 
milligrams (mg); ANDA 084678, Chlordiazepoxide HCl Capsules, 5 mg; and 
ANDA 084679, Chlordiazepoxide HCl Capsules, 25 mg. Before FDA withdrew 
the approval of these ANDAs, Upsher-Smith Laboratories, LLC., informed 
FDA that it did not want the approval of the ANDAs withdrawn. Because 
Upsher-Smith Laboratories, LLC., timely requested that approval of 
these ANDAs not be withdrawn, the approval of ANDAs 084041, 084678, and 
084679 is still in effect. In addition, the document indicated that FDA 
was withdrawing approval of ANDA 206061, Pravastatin Sodium Tablets, 20 
mg, 40 mg, and 80 mg, after receiving a request from Hisun 
Pharmaceutical (Hangzhou) Co., Ltd. However, the document published 
with the incorrect applicant name for ANDA 206061. This document 
corrects that error. All other information for ANDA 206061 remains the 
same.

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 Friday, January 
15, 2021 (86 FR 4081), appearing on page 4081 in FR Doc. 2021-00833, 
the following corrections are made on page 4082 in the table:
    1. The entries for ANDAs 084041, 084678, and 084679 are removed.
    2. In the third column, third item from the bottom, the applicant 
name ``Hisun Pharmaceuticals USA, Inc.'' is corrected to read ``Hisun 
Pharmaceuticals USA, Inc., U.S. Agent for Hisun Pharmaceutical 
(Hangzhou) Co., Ltd.'' for ANDA 206061.

    Dated: March 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06745 Filed 3-31-21; 8:45 am]
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