Application 017598
- Type
- NDA
- Sponsor
- MONARCH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SEPTRA | SULFAMETHOXAZOLE; TRIMETHOPRIM | SUSPENSION;ORAL | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | SEPTRA GRAPE | SULFAMETHOXAZOLE; TRIMETHOPRIM | SUSPENSION;ORAL | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |