Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017560
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACTRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | Yes | No |
| BACTRIM PEDIATRIC | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/21/2025 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017560s047lbl.pdf | |
| 06/24/2024 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017560s046lbl.pdf | |
| 05/21/2021 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017560s045lbl.pdf | |
| 07/28/2020 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017560s044lbl.pdf |