Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212231
Company: SOMERSET
Company: SOMERSET
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 |
---|---|---|---|---|---|---|---|
06/26/2019 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
09/22/2022 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
09/22/2022 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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 |