| NDC Code | 52427-816-01 |
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| Package Description | 1 BOTTLE in 1 CARTON (52427-816-01) / 100 TABLET, FILM COATED in 1 BOTTLE |
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| Product NDC | 52427-816 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Stalevo |
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| Non-Proprietary Name | Carbidopa, Levodopa, And Entacapone |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20201005 |
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| Marketing Category Name | NDA |
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| Application Number | NDA021485 |
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| Manufacturer | Almatica Pharma LLC |
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| Substance Name | CARBIDOPA; ENTACAPONE; LEVODOPA |
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| Strength | 25; 200; 100 |
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| Strength Unit | mg/1; mg/1; mg/1 |
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| Pharmacy Classes | Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC] |
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