Mirapex - pramipexole dihydrochloride
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Field |
Value |
NDC Code: |
0597-0109 |
Proprietary Name: |
Mirapex |
Suffix: |
ER |
Non-Proprietary Name: |
pramipexole dihydrochloride |
Dosage Form: |
TABLET, EXTENDED RELEASE |
Method: |
ORAL |
Original Marketing Date: |
22-02-2010 |
Category Name: |
NDA |
Application Number: |
NDA022421 |
Labeler: |
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. |
Substance Name: |
PRAMIPEXOLE DIHYDROCHLORIDE |
Active Numerator Strength: |
.375 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |
DEA Schedule: |
|