| NDC Code | 33342-214-12 |
|---|
| Package Description | 10 BLISTER PACK in 1 CARTON (33342-214-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
|---|
| Product NDC | 33342-214 |
|---|
| 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 | 20200824 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA206156 |
|---|
| Manufacturer | Macleods Pharmaceuticals Limited |
|---|
| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
|---|
| Strength | 4.5 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |
|---|