Application 201963
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | No | No |
| 002 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | No | No |
| 003 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1.5MG | No | No |
| 004 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 3MG | No | No |
| 005 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 4.5MG | No | No |