Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070048
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COTRIM D.S. 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
03/18/1985 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
08/26/2014 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

08/30/2001 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

01/07/1997 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/22/1996 SUPPL-36 Labeling

Label is not available on this site.

10/03/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/04/1994 SUPPL-31 Labeling

Label is not available on this site.

01/26/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/29/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/29/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/23/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/01/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/17/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/17/1991 SUPPL-19 Labeling

Label is not available on this site.

01/12/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/06/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/23/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/23/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/08/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/09/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/09/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/09/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/23/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/08/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/30/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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