Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070006
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG 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-27 Manufacturing (CMC)

Label is not available on this site.

05/13/1998 SUPPL-26 Labeling

Label is not available on this site.

10/22/1997 SUPPL-25 Labeling

Label is not available on this site.

12/23/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/12/1994 SUPPL-22 Labeling

Label is not available on this site.

04/03/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/24/1991 SUPPL-18 Labeling

Label is not available on this site.

02/22/1990 SUPPL-17 Labeling

Label is not available on this site.

05/17/1989 SUPPL-16 Labeling

Label is not available on this site.

06/09/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/08/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/06/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/31/1987 SUPPL-11 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.

08/30/1985 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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