Product NDC: | 57664-002 |
Proprietary Name: | Pramipexole |
Non Proprietary Name: | Pramipexole |
Active Ingredient(s): | .25 mg/1 & nbsp; Pramipexole |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 57664-002 |
Labeler Name: | Caraco Pharmaceutical Laboratories, Ltd. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091683 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130523 |
Package NDC: | 57664-002-13 |
Package Description: | 500 TABLET in 1 BOTTLE (57664-002-13) |
NDC Code | 57664-002-13 |
Proprietary Name | Pramipexole |
Package Description | 500 TABLET in 1 BOTTLE (57664-002-13) |
Product NDC | 57664-002 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Pramipexole |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20130523 |
Marketing Category Name | ANDA |
Labeler Name | Caraco Pharmaceutical Laboratories, Ltd. |
Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
Strength Number | .25 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |