Drugs@FDA: FDA-Approved Drugs
Company: AMNEAL PHARMS NY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET;ORAL | Prescription | AB | No | No |
SULFAMETHOXAZOLE AND TRIMETHOPRIM | 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 |
---|---|---|---|---|---|---|---|
01/27/2005 | 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 |
---|---|---|---|---|---|
09/16/2022 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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09/16/2022 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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12/21/2014 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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02/20/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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03/22/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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03/17/2011 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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08/14/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/16/2007 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/20/2008 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
SULFAMETHOXAZOLE AND TRIMETHOPRIM
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 |
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 |