| NDC Code | 0378-4093-77 |
|---|
| Package Description | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4093-77) |
|---|
| Product NDC | 0378-4093 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Ropinirole Hydrochloride |
|---|
| Non-Proprietary Name | Ropinirole Hydrochloride |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20121016 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA200462 |
|---|
| Manufacturer | Mylan Pharmaceuticals Inc. |
|---|
| Substance Name | ROPINIROLE HYDROCHLORIDE |
|---|
| Strength | 8 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |
|---|