| Product NDC: | 55648-775 |
| Proprietary Name: | Ropinirole Hydrochloride |
| Non Proprietary Name: | Ropinirole Hydrochloride |
| Active Ingredient(s): | 12 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: | 55648-775 |
| Labeler Name: | Wockhardt Limited |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA091395 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120815 |
| Package NDC: | 55648-775-03 |
| Package Description: | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-775-03) |
| NDC Code | 55648-775-03 |
| Proprietary Name | Ropinirole Hydrochloride |
| Package Description | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-775-03) |
| Product NDC | 55648-775 |
| 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 | 12 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |