Application 216604
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | No | No |
| 002 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | No | No |