Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018812
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Discontinued None No No
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;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
01/28/1983 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-57 Manufacturing (CMC)-Facility

Label is not available on this site.

02/02/1998 SUPPL-56 Labeling

Label is not available on this site.

12/16/1997 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

10/17/1997 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

05/13/1997 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

12/04/1996 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

12/04/1996 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

09/25/1995 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

12/14/1994 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

05/16/1994 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

04/04/1994 SUPPL-46 Labeling

Label is not available on this site.

05/17/1993 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

05/13/1992 SUPPL-43 Labeling

Label is not available on this site.

05/13/1992 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-41 Labeling

Label is not available on this site.

05/03/1990 SUPPL-40 Labeling

Label is not available on this site.

11/14/1988 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/26/1987 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/14/1988 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/22/1987 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/22/1987 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/13/1986 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/13/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/19/1986 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/19/1986 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/07/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/07/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/01/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/01/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/17/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/08/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/24/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/08/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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