Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018615
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFATRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Discontinued None No No
SULFATRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription AB 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
01/07/1983 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
09/07/2016 SUPPL-76 Labeling-Container/Carton Labels, 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.

09/25/2003 SUPPL-56 Labeling

Label is not available on this site.

02/07/2001 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/2000 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1997 SUPPL-51 Labeling

Label is not available on this site.

01/07/1997 SUPPL-50 Labeling

Label is not available on this site.

06/20/1997 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

02/28/1997 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-46 Labeling

Label is not available on this site.

01/07/1997 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/08/1995 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/19/1994 SUPPL-38 Labeling

Label is not available on this site.

02/16/1994 SUPPL-37 Labeling

Label is not available on this site.

11/03/1993 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

11/03/1993 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/03/1993 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/03/1993 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/05/1993 SUPPL-32 Bioequivalence

Label is not available on this site.

09/28/1990 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

07/24/1991 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/22/1993 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/08/1990 SUPPL-28 Labeling

Label is not available on this site.

01/12/1990 SUPPL-26 Labeling

Label is not available on this site.

12/15/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/26/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/26/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-20 Labeling

Label is not available on this site.

07/14/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/08/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/27/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/22/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/22/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/13/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/13/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/13/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/13/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

SULFATRIM

There are no Therapeutic Equivalents.

SULFATRIM PEDIATRIC

SUSPENSION;ORAL; 200MG/5ML;40MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 091348 AUROBINDO PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 074650 HI TECH PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 077785 LANNETT CO INC
SULFATRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 018615 PHARM ASSOC

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