Document ID: FDA-2019-N-4590-0002
Agency: fda
Document Type: Notice
Title: Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 21 
Abbreviated New Drug Applications; Correction
Posted Date: 2021-07-12T04:00Z

[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Page 36562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14717]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4590]

Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of 
Approval of 21 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 December 2, 2019. The document 
announced the withdrawal of approval of 21 abbreviated new drug 
applications (ANDAs) from multiple applicants, effective January 2, 
2020. The document erroneously included ANDA 076709 for Fentanyl 
Extended-Release Film, 25 micrograms (mcg)/hour (hr), 50 mcg/hr, 75 
mcg/hr, 100 mcg/hr, held by Actavis Laboratories UT, Inc., Subsidiary 
of Teva Pharmaceuticals USA, Inc., 577 Chipeta Way, Salt Lake City, UT 
84108, and ANDA 077062 for Fentanyl Extended-Release Film, 25 mcg/hr, 
50 mcg/hr, 75 mcg/hr, and 100 mcg/hr, held by Mayne Pharma LLC, 1240 
Sugg Parkway, Greenville, NC 27834. This correction is being made 
because FDA previously withdrew the approval of ANDAs 076709 and 077062 
in the Federal Register of November 18, 2019. This notice 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, Martha.Nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, December 
2, 2019, 84 FR 65986, appearing on page 65986 in FR Doc. 2019-25946, 
the following correction is made:
    On page 65986, in the table, the entries for ANDAs 076709 and 
077062 are removed.

    Dated: July 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14717 Filed 7-9-21; 8:45 am]
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