| NDC Code | 68382-476-06 |
|---|
| Package Description | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-476-06) |
|---|
| Product NDC | 68382-476 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Pramipexole Dihydrochloride |
|---|
| Non-Proprietary Name | Pramipexole Dihydrochloride |
|---|
| Dosage Form | TABLET, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20180424 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA202891 |
|---|
| Manufacturer | Zydus Pharmaceuticals USA Inc. |
|---|
| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
|---|
| Strength | 1.5 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |
|---|