Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017377
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription AB Yes No
BACTRIM DS SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription AB Yes Yes
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 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/18/2016 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

11/27/2015 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

04/13/2015 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

04/07/2015 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

07/16/2014 SUPPL-74 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017377s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017377Orig1s074ltr.pdf
07/12/2013 SUPPL-73 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017377Orig1s068,s073ltr.pdf
08/29/2012 SUPPL-71 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017377s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017377Orig1s071ltr.pdf
07/12/2013 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017377Orig1s068,s073ltr.pdf
07/27/2010 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017377s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017377s067ltr.pdf
06/28/2010 SUPPL-66 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017377s066ltr.pdf
06/05/2007 SUPPL-63 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017377s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017377s063ltr.pdf
10/17/2002 SUPPL-58 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17377s58lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17377scf058ltr.pdf
02/12/2003 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17377slr057_Bactrim_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17377slr057ltr.pdf
11/17/1998 SUPPL-56 Labeling

Label is not available on this site.

04/18/1994 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/03/2000 SUPPL-53 Labeling

Label is not available on this site.

07/17/1990 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

07/03/2000 SUPPL-50 Labeling

Label is not available on this site.

05/11/1987 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1987 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1996 SUPPL-47 Labeling

Label is not available on this site.

08/11/1987 SUPPL-46 Labeling

Label is not available on this site.

03/19/1985 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1984 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1984 SUPPL-43 Labeling

Label is not available on this site.

05/09/1984 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1983 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/15/1990 SUPPL-40 Efficacy-New Indication

Label is not available on this site.

06/15/1983 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1981 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1981 SUPPL-36 Labeling

Label is not available on this site.

04/23/1981 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1981 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1980 SUPPL-33 Labeling

Label is not available on this site.

02/23/1982 SUPPL-32 Efficacy

Label is not available on this site.

03/06/1980 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1979 SUPPL-30 Labeling

Label is not available on this site.

04/18/1979 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/1978 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1978 SUPPL-27 Labeling

Label is not available on this site.

04/18/1978 SUPPL-26 Labeling

Label is not available on this site.

03/01/1978 SUPPL-25 Labeling

Label is not available on this site.

01/12/1978 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1979 SUPPL-23 Labeling

Label is not available on this site.

05/02/1977 SUPPL-22 Labeling

Label is not available on this site.

01/19/1977 SUPPL-21 Labeling

Label is not available on this site.

11/22/1976 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1976 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1977 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1976 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/12/1976 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1975 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1975 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1974 SUPPL-10 Labeling

Label is not available on this site.

12/05/1974 SUPPL-9 Labeling

Label is not available on this site.

01/22/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1974 SUPPL-4

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/16/2014 SUPPL-74 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017377s074lbl.pdf
07/12/2013 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf
07/12/2013 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf
08/29/2012 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017377s071lbl.pdf
07/27/2010 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017377s067lbl.pdf
06/05/2007 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017377s063lbl.pdf
02/12/2003 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17377slr057_Bactrim_lbl.pdf
10/17/2002 SUPPL-58 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17377s58lbl.pdf

BACTRIM

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 076817 VISTA PHARMS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 070030 TEVA PHARMS

BACTRIM 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
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 070037 TEVA

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