Application 217186
- Type
- NDA
- Sponsor
- IMPAX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CREXONT | CARBIDOPA; LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 35MG;140MG | Yes | No |
| 002 | CREXONT | CARBIDOPA; LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 52.5MG;210MG | Yes | No |
| 003 | CREXONT | CARBIDOPA; LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 70MG;280MG | Yes | No |
| 004 | CREXONT | CARBIDOPA; LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 87.5MG;350MG | Yes | Yes |