Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070028
Company: ANI PHARMS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/29/1985 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
05/31/2002 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

08/30/2000 SUPPL-29 Labeling

Label is not available on this site.

05/29/2001 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/02/1999 SUPPL-26 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

02/12/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/04/1998 SUPPL-20 Labeling

Label is not available on this site.

01/30/1998 SUPPL-19 Labeling

Label is not available on this site.

05/09/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/22/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/07/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/07/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/07/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/07/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/07/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/07/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/07/1994 SUPPL-9 Labeling

Label is not available on this site.

12/20/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/20/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/20/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/28/1990 SUPPL-5 Labeling

Label is not available on this site.

06/28/1990 SUPPL-4 Labeling

Label is not available on this site.

04/28/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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