Document ID: FDA-2021-N-1037-0002
Agency: fda
Document Type: Notice
Title: Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications; Correction
Posted Date: 2022-01-18T05:00Z

[Federal Register Volume 87, Number 11 (Tuesday, January 18, 2022)]
[Notices]
[Page 2616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00831]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1037]

Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 
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 October 22, 2021. The document 
announced the withdrawal of approval of 216 abbreviated new drug 
applications (ANDAs) from multiple applicants, as of November 22, 2021. 
The document was published with an incorrect date. In addition, the 
document indicated that FDA was withdrawing approval of ANDA 075941, 
Strontium Chloride SR-89 Injection, 1 millicurie/milliliter, held by 
Bio-Nucleonics, Inc., 1600 Market St., Suite 13200, Philadelphia, PA 
19103, for repeated failure to submit annual reports. Before FDA 
withdrew the approval of this ANDA, the application holder informed FDA 
that it submitted annual reports for ANDA 075941. Therefore, FDA 
rescinds its withdrawal of approval of ANDA 075941. The approval of 
ANDA 075941 is still in effect.

FOR FURTHER INFORMATION CONTACT: James Hanratty, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-
402-4718, [email protected].

SUPPLEMENTARY INFORMATION:

Corrections

    In the Federal Register of Friday, October 22, 2021 (86 FR 58675), 
in FR Doc. 2021-23075, the following corrections are made:
    1. On page 58675, in the second column, correct the DATES section 
to read: DATES: Approval is withdrawn as of October 22, 2021.''
    2. On page 58679, in the table, remove the entry for ANDA 075941.

    Dated: January 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00831 Filed 1-14-22; 8:45 am]
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