Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017377
Company: SUN PHARM INDUSTRIES
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 |
|---|---|---|---|---|---|
| 04/30/2021 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017377s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017377Orig1s083ltr.pdf | |
| 07/28/2020 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017377s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017377Orig1s080ltr.pdf | |
| 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) |
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/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 |
|---|---|---|---|---|---|
| 04/30/2021 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017377s083lbl.pdf | |
| 07/28/2020 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017377s080lbl.pdf | |
| 07/16/2014 | SUPPL-74 | Labeling-Container/Carton Labels | 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/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 PHARMS LTD |
| 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 |
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 PHARMS LTD |
| 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 |