| NDC Code | 71904-200-03 |
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| Package Description | 25 VIAL, GLASS in 1 CARTON (71904-200-03) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
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| Product NDC | 71904-200 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Pombiliti |
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| Proprietary Name Suffix | Atga |
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| Non-Proprietary Name | Cipaglucosidase Alfa-atga |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20231011 |
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| Marketing Category Name | BLA |
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| Application Number | BLA761204 |
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| Manufacturer | AMICUS THERAPEUTICS US, LLC |
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| Substance Name | CIPAGLUCOSIDASE ALFA |
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| Strength | 105 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC], alpha-Glucosidases [CS] |
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