FDA.reportPublic FDA data

Application 212601

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENTACAPONEENTACAPONETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-478ENTACAPONEENTACAPONEAlembic Pharmaceuticals LimitedANDACurrent
62332-478ENTACAPONEENTACAPONEAlembic Pharmaceuticals Inc.ANDACurrent