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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087003
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROXICET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG 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
02/25/1980 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
03/07/2024 SUPPL-47 Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-46 Labeling-Package Insert

Label is not available on this site.
03/04/2021 SUPPL-45 Labeling-Package Insert

Label is not available on this site.
10/08/2019 SUPPL-43 Labeling-Package Insert

Label is not available on this site.
09/21/2018 SUPPL-42 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-41 REMS - PROPOSAL - D-N-A

Label is not available on this site.
12/16/2016 SUPPL-39 Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-38 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.
08/12/2014 SUPPL-36 Labeling-Container/Carton Labels

Label is not available on this site.
10/18/2013 SUPPL-35 Labeling-Package Insert

Label is not available on this site.
06/28/2011 SUPPL-34 Labeling-Package Insert

Label is not available on this site.
08/29/2007 SUPPL-27 Labeling

Label is not available on this site.
06/05/2001 SUPPL-20 Labeling

Label is not available on this site.
03/22/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
08/28/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
06/19/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
09/23/1993 SUPPL-16 Labeling

Label is not available on this site.
05/13/1993 SUPPL-15 Labeling

Label is not available on this site.
09/15/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
05/29/1991 SUPPL-13 Labeling

Label is not available on this site.
10/21/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
10/21/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
10/21/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
08/29/1989 SUPPL-9 Labeling

Label is not available on this site.
02/01/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
02/01/1991 SUPPL-7 Labeling

Label is not available on this site.
02/01/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
03/29/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
09/01/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.
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