Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087653
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG 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
04/13/1982 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
12/01/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-32 Labeling

Label is not available on this site.

12/23/1994 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/27/1991 SUPPL-27 Labeling

Label is not available on this site.

05/31/1990 SUPPL-26 Labeling

Label is not available on this site.

01/17/1989 SUPPL-25 Labeling

Label is not available on this site.

04/22/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/19/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/19/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/19/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/19/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/06/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/01/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/19/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/19/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/19/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/01/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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