Galafold
These highlights do not include all the information needed to use GALAFOLD safely and effectively. See full prescribing information for GALAFOLD. GALAFOLD (migalastat) capsules, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
66dbd928-0f1c-48b1-a832-54e4abd9f1db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 27, 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.
migalastat hydrochloride
PRODUCT DETAILS
NDC Product Code71904-100
Application NumberNDA208623
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 15, 2021
Generic Namemigalastat hydrochloride
INGREDIENTS (9)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MIGALASTAT HYDROCHLORIDEActive
Quantity: 123 mg in 1 1
Code: CLY7M0XD20
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT