Application 209885

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AUSTEDODEUTETRABENAZINETABLET;ORAL6MGNoNo
002AUSTEDODEUTETRABENAZINETABLET;ORAL9MGNoNo
003AUSTEDODEUTETRABENAZINETABLET;ORAL12MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54471ORIG2018-06-07
49621ORIG2017-08-30
49620ORIG2017-08-30