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Pombiliti
cipaglucosidase alfa-atga
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Pombiliti
Proper name
cipaglucosidase alfa-atga
Licence type
351(a)
BLA number
761204
Applicant
Amicus Therapeutics US, LLC
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 105MG | Injection | Intravenous | Single-Dose Vial | Rx | September 28, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |