Application 213096
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 225MG | No | No |
| 002 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 325MG | No | No |
| 003 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 425MG | No | No |