OPFOLDA
These highlights do not include all the information needed to use OPFOLDA™ safely and effectively. See full prescribing information for OPFOLDA. OPFOLDA (miglustat) capsules, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
d7c38298-37db-5a80-e053-2995a90aee40
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.
miglustat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71904-300
Application NumberNDA215211
Product Classification
M
Marketing Category
C73594
G
Generic Name
miglustat
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (1)
MIGLUSTATActive
Quantity: 65 mg in 1 1
Code: ADN3S497AZ
Classification: ACTIB