FDA.reportPublic FDA data

Application 208937

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOLCAPONETOLCAPONETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-193TOLCAPONEtolcaponeIngenus Pharmaceuticals, LLCANDACurrent
50742-193TOLCAPONEtolcaponeIngenus Pharmaceuticals, LLCANDACurrent