Product NDC: | 55648-771 |
Proprietary Name: | Ropinirole Hydrochloride |
Non Proprietary Name: | Ropinirole Hydrochloride |
Active Ingredient(s): | 2 mg/1 & nbsp; Ropinirole Hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 55648-771 |
Labeler Name: | Wockhardt Limited |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091395 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120815 |
Package NDC: | 55648-771-01 |
Package Description: | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-771-01) |
NDC Code | 55648-771-01 |
Proprietary Name | Ropinirole Hydrochloride |
Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-771-01) |
Product NDC | 55648-771 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Ropinirole Hydrochloride |
Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20120815 |
Marketing Category Name | ANDA |
Labeler Name | Wockhardt Limited |
Substance Name | ROPINIROLE HYDROCHLORIDE |
Strength Number | 2 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |