Application 216605
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 200MG/100ML (2MG/ML) | No | No |
| 002 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 400MG/200ML (2MG/ML) | No | No |
| 003 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 500MG/100ML (5MG/ML) | No | No |
| 004 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 1GM/200ML (5MG/ML) | No | No |