Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018854
Company: WATSON LABS
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
05/09/1983 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
12/12/2001 SUPPL-37 Labeling Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Label is not available on this site.

04/25/2001 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/2001 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/2000 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/03/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/03/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/21/1997 SUPPL-29 Labeling

Label is not available on this site.

06/17/1994 SUPPL-28 Labeling

Label is not available on this site.

02/09/1994 SUPPL-27 Labeling

Label is not available on this site.

02/25/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/29/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/26/1988 SUPPL-22 Bioequivalence

Label is not available on this site.

11/01/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/01/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/17/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/09/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/09/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/13/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/13/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/13/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/03/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/17/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/31/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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