NDC Code | 71904-200-02 |
Package Description | 10 VIAL, GLASS in 1 CARTON (71904-200-02) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
Product NDC | 71904-200 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Pombiliti |
Proprietary Name Suffix | Atga |
Non-Proprietary Name | Cipaglucosidase Alfa-atga |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Usage | INTRAVENOUS |
Start Marketing Date | 20231011 |
Marketing Category Name | BLA |
Application Number | BLA761204 |
Manufacturer | AMICUS THERAPEUTICS US, LLC |
Substance Name | CIPAGLUCOSIDASE ALFA |
Strength | 105 |
Strength Unit | mg/1 |
Pharmacy Classes | Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC], alpha-Glucosidases [CS] |