Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089008
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;5MG CAPSULE;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
02/21/1986 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
08/13/2002 SUPPL-47 Manufacturing (CMC)-Facility

Label is not available on this site.

07/31/1998 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/14/1996 SUPPL-45 Labeling

Label is not available on this site.

08/11/1995 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

03/27/1995 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

05/13/1992 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/04/1990 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/28/1991 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/14/1989 SUPPL-36 Bioequivalence

Label is not available on this site.

02/13/1991 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-30 Labeling

Label is not available on this site.

02/13/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-27 Labeling

Label is not available on this site.

02/13/1991 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/09/1989 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-22 Labeling

Label is not available on this site.

02/13/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-20 Labeling

Label is not available on this site.

06/04/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/31/1992 SUPPL-10 Labeling

Label is not available on this site.

03/31/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/23/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/14/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/31/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/23/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/14/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/14/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/29/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/29/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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