FDA.reportPublic FDA data

Application 215211

Type
NDA
Sponsor
AMICUS THERAP US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPFOLDAMIGLUSTATCAPSULE;ORAL65MGYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79239SUPPL 2024-07-29
79217SUPPL 2024-07-26
75990ORIG 2023-10-31
75620ORIG 2023-09-29
75601ORIG 2023-09-28