Product NDC: | 0054-0117 |
Proprietary Name: | Ropinirole |
Non Proprietary Name: | rOPINIRole |
Active Ingredient(s): | .5 mg/1 & nbsp; rOPINIRole |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0054-0117 |
Labeler Name: | Roxane Laboratories, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA077852 |
Marketing Category: | ANDA |
Start Marketing Date: | 20080505 |
Package NDC: | 0054-0117-25 |
Package Description: | 100 TABLET in 1 BOTTLE (0054-0117-25) |
NDC Code | 0054-0117-25 |
Proprietary Name | Ropinirole |
Package Description | 100 TABLET in 1 BOTTLE (0054-0117-25) |
Product NDC | 0054-0117 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | rOPINIRole |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20080505 |
Marketing Category Name | ANDA |
Labeler Name | Roxane Laboratories, Inc |
Substance Name | ROPINIROLE HYDROCHLORIDE |
Strength Number | .5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |