Application 020073
- Type
- NDA
- Sponsor
- HOFFMANN LA ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROMAZICON | FLUMAZENIL | INJECTABLE;INJECTION | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | ROMAZICON | FLUMAZENIL | INJECTABLE;INJECTION | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |