Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018598
Company: FOSUN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Discontinued None No No
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
05/19/1982 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
02/03/2011 SUPPL-51 Labeling-Package Insert 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.

02/20/2008 SUPPL-50 Labeling

Label is not available on this site.

06/23/2000 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/2000 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.

01/07/1998 SUPPL-36 Labeling

Label is not available on this site.

07/11/1996 SUPPL-35 Labeling

Label is not available on this site.

10/08/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/08/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/03/1996 SUPPL-32 Labeling

Label is not available on this site.

05/03/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/10/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/10/1995 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/09/1994 SUPPL-19 Labeling

Label is not available on this site.

07/28/1992 SUPPL-18 Labeling

Label is not available on this site.

10/20/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/20/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/08/1989 SUPPL-15 Labeling

Label is not available on this site.

11/07/1988 SUPPL-14 Labeling

Label is not available on this site.

03/27/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/27/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/13/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/18/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/07/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/29/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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