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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089689
Company: MIKART

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 650MG;7.5MG 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
06/29/1988 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
08/13/2002 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.
09/21/1998 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.
07/31/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.
05/28/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
05/28/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
09/05/2000 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
09/05/2000 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
09/05/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.
07/22/1997 SUPPL-32 Labeling

Label is not available on this site.
09/05/2000 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
02/08/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
03/17/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
04/08/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
02/25/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
02/25/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
05/27/1993 SUPPL-25 Labeling

Label is not available on this site.
02/08/1994 SUPPL-24 Labeling

Label is not available on this site.
02/08/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
02/08/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
10/15/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
12/18/1990 SUPPL-20 Labeling

Label is not available on this site.
10/15/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
10/15/1991 SUPPL-17 Labeling

Label is not available on this site.
10/15/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
10/15/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
02/25/1993 SUPPL-14 Labeling

Label is not available on this site.
02/25/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
02/25/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
12/18/1990 SUPPL-11 Labeling

Label is not available on this site.
12/18/1990 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
12/18/1990 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
12/18/1990 SUPPL-8 Labeling

Label is not available on this site.
12/18/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
12/18/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
12/18/1990 SUPPL-5 Labeling

Label is not available on this site.
12/18/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
12/18/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
06/30/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
04/24/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.
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