Application 207939

Type
ANDA
Sponsor
HEC PHARM CO LTD

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
64980-449fingolimodFingolimod hclRising Pharmaceuticals, Inc.ANDACurrent
64980-449fingolimodFingolimod hclRising Pharmaceuticals, Inc.ANDACurrent
64980-449fingolimodFingolimod hclRising Pharmaceuticals, Inc.ANDACurrent
64980-449fingolimodFingolimod hclRising Pharmaceuticals, Inc.ANDACurrent
64980-449fingolimodFingolimod hclRising Pharmaceuticals, Inc.ANDACurrent