Application 018452
- Type
- NDA
- Sponsor
- MONARCH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SEPTRA | SULFAMETHOXAZOLE; TRIMETHOPRIM | INJECTABLE;INJECTION | 80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |