Application 208826

Type
ANDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TETRABENAZINETETRABENAZINETABLET;ORAL12.5MGNoNo
002TETRABENAZINETETRABENAZINETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69452-117TETRABENAZINETETRABENAZINEBionpharma Inc.ANDACurrent
69452-118TETRABENAZINETETRABENAZINEBionpharma Inc.ANDACurrent