Application 090190
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 0.125MG | No | No |
| 002 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 0.25MG | No | No |
| 003 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 0.5MG | No | No |
| 004 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 1MG | No | No |
| 005 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 1.5MG | No | No |
| 006 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 0.75MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-5248 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5249 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5250 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5251 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5252 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5281 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Sandoz Inc | ANDA | Current |