Product NDC: | 0597-0113 |
Proprietary Name: | Mirapex |
Non Proprietary Name: | pramipexole dihydrochloride |
Active Ingredient(s): | 1.5 mg/1 & nbsp; pramipexole dihydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0597-0113 |
Labeler Name: | Boehringer Ingelheim Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022421 |
Marketing Category: | NDA |
Start Marketing Date: | 20100222 |
Package NDC: | 0597-0113-17 |
Package Description: | 1 BOTTLE, PLASTIC in 1 CARTON (0597-0113-17) > 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
NDC Code | 0597-0113-17 |
Proprietary Name | Mirapex |
Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (0597-0113-17) > 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
Product NDC | 0597-0113 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | pramipexole dihydrochloride |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20100222 |
Marketing Category Name | NDA |
Labeler Name | Boehringer Ingelheim Pharmaceuticals, Inc. |
Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
Strength Number | 1.5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |