Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET;ORAL | Prescription | AB | No | No |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/25/1986 | 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 |
|---|---|---|---|---|---|
| 03/31/2022 | SUPPL-72 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/31/2022 | SUPPL-70 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2014 | SUPPL-64 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/17/2013 | SUPPL-63 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2010 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2007 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 11/29/2005 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 01/27/2005 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 12/06/2002 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/2002 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/2002 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 06/06/2002 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/2002 | SUPPL-31 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 11/19/2001 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 05/17/2002 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/2000 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/2000 | SUPPL-25 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/01/2000 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1999 | SUPPL-21 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 09/14/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/29/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/23/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
SULFAMETHOXAZOLE AND TRIMETHOPRIM
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 |
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 |