NDC Code | 0597-0285-17 |
Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (0597-0285-17) > 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
Product NDC | 0597-0285 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Mirapex |
Proprietary Name Suffix | Er |
Non-Proprietary Name | Pramipexole Dihydrochloride |
Dosage Form | TABLET, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20100222 |
Marketing Category Name | NDA |
Application Number | NDA022421 |
Manufacturer | Boehringer Ingelheim Pharmaceuticals, Inc. |
Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
Strength | .75 |
Strength Unit | mg/1 |
Pharmacy Classes | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |