Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089351
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROXICET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG/5ML;5MG/5ML SOLUTION;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
12/03/1986 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
10/08/2019 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-29 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

06/28/2011 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

08/29/2007 SUPPL-23 Labeling

Label is not available on this site.

05/15/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/2001 SUPPL-17 Labeling

Label is not available on this site.

12/18/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/16/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/16/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/12/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/12/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/22/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/16/1994 SUPPL-7 Labeling

Label is not available on this site.

05/29/1991 SUPPL-6 Labeling

Label is not available on this site.

02/15/1989 SUPPL-5 Labeling

Label is not available on this site.

07/01/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/01/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/15/1989 SUPPL-2 Labeling

Label is not available on this site.

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