Application 022514
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 0.375MG | No | No |
| 002 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 0.75MG | No | No |
| 003 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 1.5MG | No | No |
| 004 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 3MG | No | No |
| 005 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 4.5MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44187 | ORIG | 2012-09-19 |
| 44767 | ORIG | 2010-09-03 |
| 42545 | ORIG | 2010-09-03 |
| 38800 | ORIG | 2010-03-26 |
| 7488 | ORIG | 2010-03-24 |