Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089231
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 650MG;30MG 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
03/03/1986 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
08/13/2002 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

10/21/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/31/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/08/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/08/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/08/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/14/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/30/1995 SUPPL-20 Labeling

Label is not available on this site.

02/08/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/08/1991 SUPPL-18 Labeling

Label is not available on this site.

07/11/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/21/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/23/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/20/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/20/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/02/1988 SUPPL-10 Labeling

Label is not available on this site.

02/08/1991 SUPPL-9 Labeling

Label is not available on this site.

02/08/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/08/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/08/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/16/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/08/1991 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.

07/14/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/06/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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