FdaApplication
NDA 020667
Identifiers
- fda_app_no: NDA020667
Properties
| Property | Value |
|---|---|
| applicant_name | BOEHRINGER INGELHEIM |
| application_type | NDA |
| approval_date | 1997-07-01 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1.25MG | TABLET;ORAL |
7 products