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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087794
Company: SUN PHARM INDUSTRIES

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE 325MG;4.5MG;0.38MG TABLET;ORAL Discontinued None No 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
05/26/1982 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
05/04/2021 SUPPL-31 Labeling-Medication Guide, Labeling-Package Insert

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.
10/09/2019 SUPPL-29 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/20/2018 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.
03/07/2017 SUPPL-26 Labeling-Package Insert

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

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

Label is not available on this site.
12/01/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
12/23/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
04/03/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
04/03/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
08/07/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
05/09/1990 SUPPL-15 Labeling

Label is not available on this site.
01/30/1990 SUPPL-14 Labeling

Label is not available on this site.
07/14/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
05/15/1989 SUPPL-12 Labeling

Label is not available on this site.
03/31/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
04/01/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
02/04/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
02/04/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
02/04/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
02/04/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
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