Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications; Correction
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Abstract
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.
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<title>Federal Register, Volume 86 Issue 130 (Monday, July 12, 2021)</title>
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[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Page 36562]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#97daf6e5e3fff6b9d9f0e2eef2f9d7f1f3f6b9ffffe4b9f0f8e1"><span class="__cf_email__" data-cfemail="96dbf7e4e2fef7b8d8f1e3eff3f8d6f0f2f7b8fefee5b8f1f9e0">[email protected]</span></a>.
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]
BILLING CODE 4164-01-P
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