Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070007
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG 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
11/14/1984 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.

05/13/1998 SUPPL-31 Labeling

Label is not available on this site.

10/22/1997 SUPPL-30 Labeling

Label is not available on this site.

12/23/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/12/1994 SUPPL-27 Labeling

Label is not available on this site.

04/03/1992 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-23 Labeling

Label is not available on this site.

07/16/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/16/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/13/1989 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/17/1989 SUPPL-19 Labeling

Label is not available on this site.

01/10/1989 SUPPL-18 Labeling

Label is not available on this site.

10/31/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/07/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/03/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/26/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/30/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/30/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/17/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/15/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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