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2020-03-07
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Mylan Institutional LLC et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications
Notices
D09002ee1c1112f30
D09002ee1c1113053
United States
Department of Health and Human Services
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United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
85 FR 13661
https://www.govinfo.gov/app/details/FR-2020-03-09/2020-04691
2020-04691
fr09mr20-62
4164-01-P
Docket No. FDA-2020-N-0601
https://www.govinfo.gov/app/details/FR-2020-03-09/2020-04691
https://www.govinfo.gov/content/pkg/FR-2020-03-09/html/2020-04691.htm
https://www.govinfo.gov/content/pkg/FR-2020-03-09/pdf/2020-04691.pdf
1 p.
13661
13661
85 FR 13661
Mylan Institutional LLC et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Federal Register Vol. 85, Issue
NOTICE
2020-04691
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2020-N-0601
4164-01-P
2020-04691
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of April 8, 2020.
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.
Martha.Nguyen@fda.hhs.gov
Federal Register
Vol. 85, no. 46
Office of the Federal Register, National Archives and Records Administration
2020-03-09
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253 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2020-03-09
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https://www.govinfo.gov/app/details/FR-2020-03-09
https://www.govinfo.gov/content/pkg/FR-2020-03-09/pdf/FR-2020-03-09.pdf
https://www.govinfo.gov/content/pkg/FR-2020-03-09/xml/FR-2020-03-09.xml
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