Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085795
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;15MG 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-32 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-31 Labeling

Label is not available on this site.

12/23/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/05/1991 SUPPL-26 Labeling

Label is not available on this site.

05/31/1990 SUPPL-25 Labeling

Label is not available on this site.

09/22/1988 SUPPL-23 Labeling

Label is not available on this site.

06/09/1989 SUPPL-22 Labeling

Label is not available on this site.

03/03/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/03/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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