| NDC Code | 68382-198-10 |
|---|
| Package Description | 1000 TABLET in 1 BOTTLE (68382-198-10) |
|---|
| Product NDC | 68382-198 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Pramipexole Dihydrochloride |
|---|
| Non-Proprietary Name | Pramipexole Dihydrochloride |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20100710 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA078920 |
|---|
| Manufacturer | Zydus Pharmaceuticals USA Inc. |
|---|
| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
|---|
| Strength | .5 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |
|---|