| NDC Code | 72769-101-01 |
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| Package Description | 4 DOSE PACK in 1 CARTON (72769-101-01) / 1 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE in 1 BLISTER PACK |
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| Product NDC | 72769-101 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Orladeyo |
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| Non-Proprietary Name | Berotralstat Hydrochloride |
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| Dosage Form | CAPSULE |
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| Usage | ORAL |
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| Start Marketing Date | 20201204 |
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| Marketing Category Name | NDA |
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| Application Number | NDA214094 |
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| Manufacturer | BioCryst Pharmaceuticals Inc. |
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| Substance Name | BEROTRALSTAT HYDROCHLORIDE |
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| Strength | 150 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kallikrein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC] |
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