Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017376
Company: MONARCH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription AB No No
SEPTRA DS SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;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
07/30/1973 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017376Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/15/2020 SUPPL-65 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s065lbl.pdf
08/10/2020 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s063s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017376Orig1s063,s064ltr.pdf
08/10/2020 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s063s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017376Orig1s063,s064ltr.pdf
11/18/2020 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017376Orig1s062ltr.pdf
02/01/2018 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017376s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017376Orig1s061ltr.pdf
08/30/2013 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017376s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017376Orig1s060ltr.pdf
09/10/2007 SUPPL-59 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017376s059,017598s041ltr.pdf
03/11/2008 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017376s058, 017598s040, 018452s025ltr.pdf
07/28/2005 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017376s056,017598s039ltr.pdf
10/04/2000 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/31/2000 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

02/12/1997 SUPPL-53 Labeling

Label is not available on this site.

04/07/1998 SUPPL-52 Labeling

Label is not available on this site.

03/19/1997 SUPPL-51 Labeling

Label is not available on this site.

09/11/1996 SUPPL-48 Labeling

Label is not available on this site.

01/07/1994 SUPPL-47 Labeling

Label is not available on this site.

02/22/1993 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

12/01/1992 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

03/19/1997 SUPPL-44 Labeling

Label is not available on this site.

03/19/1997 SUPPL-42 Labeling

Label is not available on this site.

06/15/1990 SUPPL-41 Efficacy-New Indication

Label is not available on this site.

02/02/1989 SUPPL-40 Labeling

Label is not available on this site.

11/09/1990 SUPPL-39 Labeling

Label is not available on this site.

08/09/1985 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1987 SUPPL-37 Labeling

Label is not available on this site.

01/16/1985 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/25/1983 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/1982 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/01/1984 SUPPL-31 Labeling

Label is not available on this site.

04/27/1982 SUPPL-30 Labeling

Label is not available on this site.

11/03/1981 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1981 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/09/1981 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/31/1980 SUPPL-26 Labeling

Label is not available on this site.

09/09/1980 SUPPL-25 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/28/1980 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1978 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/08/1978 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1979 SUPPL-21 Efficacy

Label is not available on this site.

07/05/1977 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/21/1977 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/11/1978 SUPPL-17 Efficacy

Label is not available on this site.

11/22/1976 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/22/1976 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/07/1977 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/27/1976 SUPPL-12 Labeling

Label is not available on this site.

02/12/1976 SUPPL-10 Labeling

Label is not available on this site.

11/25/1974 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/1974 SUPPL-5 Labeling

Label is not available on this site.

05/01/1974 SUPPL-3

Label is not available on this site.

10/08/1974 SUPPL-2

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/18/2020 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s062lbl.pdf
08/10/2020 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s063s064lbl.pdf
08/10/2020 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s063s064lbl.pdf
07/15/2020 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017376s065lbl.pdf
02/01/2018 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017376s061lbl.pdf
08/30/2013 SUPPL-60 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017376s060lbl.pdf
03/11/2008 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf
09/10/2007 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf
07/28/2005 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf

SEPTRA

TABLET;ORAL; 400MG;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription Yes AB 017377 SUN PHARM INDUSTRIES
SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 017376 MONARCH PHARMS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 076899 AMNEAL PHARMS NY
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 090624 AUROBINDO PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 078060 CHARTWELL MOLECULES
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 090828 GLENMARK GENERICS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 071017 SUN PHARM INDUSTRIES
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 076817 VISTA PHARMS

SEPTRA DS

TABLET;ORAL; 800MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACTRIM DS SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription Yes AB 017377 SUN PHARM INDUSTRIES
SEPTRA DS SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 017376 MONARCH PHARMS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 076899 AMNEAL PHARMS NY
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 090624 AUROBINDO PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 078060 CHARTWELL MOLECULES
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 090828 GLENMARK GENERICS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 071017 SUN PHARM INDUSTRIES
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 076817 VISTA PHARMS

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