FDA.reportPublic FDA data

Application 207993

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDECAPSULE;ORALEQ 0.5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-4332FingolimodFingolimodApotex Corp.ANDACurrent
60505-4332FingolimodFingolimodApotex Corp.ANDACurrent
60505-4332FingolimodFingolimodApotex Corp.ANDACurrent