Drugs@FDA: FDA-Approved Drugs
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 80MG/ML;16MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
10/31/1991 | 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 |
---|---|---|---|---|---|
04/29/2013 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/073303s030lbl.pdf | |
02/27/2013 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
04/29/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
07/23/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/26/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/27/1996 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/03/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/26/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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11/03/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/05/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/07/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/29/2013 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/073303s030lbl.pdf |
SULFAMETHOXAZOLE AND TRIMETHOPRIM
INJECTABLE;INJECTION; 80MG/ML;16MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 80MG/ML;16MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206607 | MYLAN LABS LTD |
SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 80MG/ML;16MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212231 | SOMERSET |
SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 80MG/ML;16MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 073303 | TEVA PHARMS USA |