Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018615
Company: PHARM ASSOC
Company: PHARM ASSOC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFATRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION;ORAL | Discontinued | None | No | No |
| SULFATRIM PEDIATRIC | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION;ORAL | Prescription | AB | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/21/2025 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018615s086lbl.pdf | |
| 06/24/2024 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018615s083lbl.pdf | |
| 10/15/2021 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018615s080lbl.pdf |