| NDC Code | 71904-200-01 |
|---|
| Package Description | 1 VIAL, GLASS in 1 CARTON (71904-200-01) / 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] |
|---|