FdaApplication
ANDA 218112
Identifiers
- fda_app_no: ANDA218112
Properties
| Property | Value |
|---|---|
| applicant_name | SOMERSET THERAPEUTICS LLC |
| application_type | ANDA |
| approval_date | 2024-09-24 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) | SOLUTION;INTRAVENOUS |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) | SOLUTION;INTRAVENOUS |
2 products