Application 218112
- Type
- ANDA
- Sponsor
- SOMERSET
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) | No | No |
| 002 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) | No | No |