FdaApplication
ANDA 216605
Identifiers
- fda_app_no: ANDA216605
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2023-03-07 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 500MG/100ML (5MG/ML) | SOLUTION;INJECTION |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 400MG/200ML (2MG/ML) | SOLUTION;INJECTION |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 1GM/200ML (5MG/ML) | SOLUTION;INJECTION |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML) | SOLUTION;INJECTION |
4 products