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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085106
Company: ENDO OPERATIONS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/31/1976 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2024 SUPPL-33 REMS - MODIFIED - D-N-A

Label is not available on this site.
04/03/2024 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/18/2023 SUPPL-31 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/04/2021 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/08/2019 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/21/2018 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-27 REMS - PROPOSAL - D-N-A

Label is not available on this site.
12/16/2016 SUPPL-26 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/16/2016 SUPPL-25 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/16/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.
10/18/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.
06/29/2011 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
05/16/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
04/30/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
04/30/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
04/30/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
04/30/1992 SUPPL-16 Labeling

Label is not available on this site.
04/30/1992 SUPPL-15 Labeling

Label is not available on this site.
03/10/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
03/10/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
03/03/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
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