Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089238
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;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
02/25/1986 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-14 Manufacturing (CMC)-Facility

Label is not available on this site.

07/31/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/05/1995 SUPPL-12 Labeling

Label is not available on this site.

07/20/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/21/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/20/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/20/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/18/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/16/1991 SUPPL-3 Labeling

Label is not available on this site.

06/04/1987 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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