| NDC Code | 68382-478-77 |
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| Package Description | 10 BLISTER PACK in 1 CARTON (68382-478-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-478-30) |
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| Product NDC | 68382-478 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Pramipexole Dihydrochloride |
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| Non-Proprietary Name | Pramipexole Dihydrochloride |
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| Dosage Form | TABLET, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20180424 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA202891 |
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| Manufacturer | Zydus Pharmaceuticals USA Inc. |
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| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
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| Strength | 4.5 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |
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