Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018242
Company: TEVA
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
SULFAMETHOXAZOLE AND TRIMETHOPRIM 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
05/19/1981 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
07/07/2000 SUPPL-50 Manufacturing (CMC)-Facility

Label is not available on this site.

02/02/1998 SUPPL-49 Labeling

Label is not available on this site.

07/12/1996 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

07/12/1996 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/18/1996 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

03/18/1996 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

01/12/1995 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/30/1994 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

02/04/1994 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

04/04/1994 SUPPL-37 Labeling

Label is not available on this site.

04/13/1993 SUPPL-36 Labeling

Label is not available on this site.

02/04/1994 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/07/1992 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-33 Labeling

Label is not available on this site.

12/04/1989 SUPPL-32 Labeling

Label is not available on this site.

11/07/1988 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/06/1988 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/13/1988 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/27/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/27/1986 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/17/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/17/1985 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/18/1984 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/18/1984 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/18/1984 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/25/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/29/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/18/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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