Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070037
Company: HERITAGE PHARMA
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
09/19/1985 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
01/15/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

12/05/2012 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

09/28/2010 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

11/01/2007 SUPPL-34 Labeling

Label is not available on this site.

06/21/2005 SUPPL-33 Labeling

Label is not available on this site.

01/03/2003 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/09/2001 SUPPL-29 Labeling

Label is not available on this site.

08/25/2000 SUPPL-27 Labeling

Label is not available on this site.

03/20/2000 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

03/20/2000 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

03/18/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/18/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/21/1998 SUPPL-15 Labeling

Label is not available on this site.

04/24/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/14/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/24/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/10/1996 SUPPL-10 Labeling

Label is not available on this site.

05/20/1994 SUPPL-8 Labeling

Label is not available on this site.

02/08/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/12/1991 SUPPL-6 Labeling

Label is not available on this site.

04/22/1991 SUPPL-5 Labeling

Label is not available on this site.

02/23/1991 SUPPL-4 Labeling

Label is not available on this site.

06/21/1990 SUPPL-3 Labeling

Label is not available on this site.

04/27/1989 SUPPL-2 Labeling

Label is not available on this site.

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