| NDC Code | 71904-300-03 |
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| Package Description | 100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC |
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| Product NDC | 71904-300 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Opfolda |
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| Non-Proprietary Name | Miglustat |
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| Dosage Form | CAPSULE |
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| Usage | ORAL |
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| Start Marketing Date | 20231011 |
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| Marketing Category Name | NDA |
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| Application Number | NDA215211 |
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| Manufacturer | AMICUS THERAPEUTICS US, LLC |
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| Substance Name | MIGLUSTAT |
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| Strength | 65 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Enzyme Stabilizer [EPC], Enzyme Stabilizers [MoA], Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA] |
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