FDA.reportPublic FDA data

Application 207682

Type
ANDA
Sponsor
MYLAN

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
42291-806TetrabenazineTetrabenazineAvKARE, Inc.ANDACurrent
42291-806TetrabenazineTetrabenazineAvKAREANDACurrent
42291-807TetrabenazineTetrabenazineAvKARE, Inc.ANDACurrent
42291-807TetrabenazineTetrabenazineAvKAREANDACurrent
51224-425TETRABENAZINETETRABENAZINETAGI Pharma, Inc.ANDACurrent
51224-426TETRABENAZINETETRABENAZINETAGI Pharma, Inc.ANDACurrent