FDA.reportPublic FDA data

Application 206093

Type
ANDA
Sponsor
APOTEX

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
51407-480TetrabenazinetetrabenazineGolden State Medical Supply, Inc.ANDACurrent
51407-480TetrabenazinetetrabenazineGolden State Medical Supply, Inc.ANDACurrent
51407-481TetrabenazinetetrabenazineGolden State Medical Supply, Inc.ANDACurrent
51407-481TetrabenazinetetrabenazineGolden State Medical Supply, Inc.ANDACurrent
60505-3882TetrabenazinetetrabenazineApotex Corp.ANDACurrent
60505-3882TetrabenazinetetrabenazineApotex Corp.ANDACurrent
60505-3883TetrabenazinetetrabenazineApotex Corp.ANDACurrent
60505-3883TetrabenazinetetrabenazineApotex Corp.ANDACurrent