FDA.reportPublic FDA data

Application 213621

Type
ANDA
Sponsor
AJANTA PHARMA LTD

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
27241-176TetrabenazineTetrabenazineAjanta Pharma USA Inc.ANDACurrent
27241-176TetrabenazineTetrabenazineAjanta Pharma LimitedANDACurrent
27241-177TetrabenazineTetrabenazineAjanta Pharma USA Inc.ANDACurrent
27241-177TetrabenazineTetrabenazineAjanta Pharma LimitedANDACurrent