Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085794
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;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
01/20/1978 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-47 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-46 Labeling

Label is not available on this site.

12/23/1994 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/05/1991 SUPPL-41 Labeling

Label is not available on this site.

12/22/1989 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/09/1989 SUPPL-39 Labeling

Label is not available on this site.

05/24/1990 SUPPL-38 Labeling

Label is not available on this site.

05/24/1990 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/24/1990 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/18/1988 SUPPL-35 Labeling

Label is not available on this site.

05/24/1990 SUPPL-34 Labeling

Label is not available on this site.

05/06/1988 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/31/1987 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/06/1988 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/26/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/26/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/01/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/01/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/01/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/01/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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