Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081223
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 650MG;10MG 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
05/29/1992 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-18 Manufacturing (CMC)-Facility

Label is not available on this site.

07/31/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/18/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/18/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/31/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/31/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/31/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/25/1996 SUPPL-11 Labeling

Label is not available on this site.

08/31/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/11/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/12/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/12/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/08/1994 SUPPL-5 Labeling

Label is not available on this site.

02/08/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/08/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/08/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/30/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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