POMBILITI
These highlights do not include all the information needed to use POMBILITI™ safely and effectively. See full prescribing information for POMBILITI. POMBILITI (cipaglucosidase alfa-atga) for injection, for intravenous use Initial U.S. Approval: 2023
Approved
Approval ID
d77aa596-910d-516b-e053-2995a90a0839
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2023
Manufacturers
FDA
AMICUS THERAPEUTICS US, LLC
DUNS: 080932337
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cipaglucosidase alfa-atga
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71904-200
Application NumberBLA761204
Product Classification
M
Marketing Category
C73585
G
Generic Name
cipaglucosidase alfa-atga
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (1)
CIPAGLUCOSIDASE ALFAActive
Quantity: 105 mg in 1 1
Code: 4SED7F4BSG
Classification: ACTIB