FdaApplication
NDA 020073
Identifiers
- fda_app_no: NDA020073
Properties
| Property | Value |
|---|---|
| applicant_name | HOFFMANN LA ROCHE INC |
| application_type | NDA |
| approval_date | 1991-12-20 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROMAZICON | FLUMAZENIL | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| ROMAZICON | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
2 products