Product Details for: Pombiliti
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
105MG
Single-Dose Vial
351(a)
Pombiliti
Rx
Proper Name
cipaglucosidase alfa-atga
cipaglucosidase alfa-atga
BLA Number
761204
761204
Applicant
Amicus Therapeutics US, LLC
Amicus Therapeutics US, LLC
Original Approval Date
September 28, 2023
September 28, 2023
Date of First Licensure