Application 216159
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | No | No |
| 002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74147 | ORIG | 2023-05-02 |