Application 216354

Type
NDA
Sponsor
TEVA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001AUSTEDO XRDEUTETRABENAZINETABLET, EXTENDED RELEASE;ORAL6MGYesNo
002AUSTEDO XRDEUTETRABENAZINETABLET, EXTENDED RELEASE;ORAL12MGYesNo
003AUSTEDO XRDEUTETRABENAZINETABLET, EXTENDED RELEASE;ORAL24MGYesNo
004AUSTEDO XRDEUTETRABENAZINETABLET, EXTENDED RELEASE;ORAL30MGYesNo
005AUSTEDO XRDEUTETRABENAZINETABLET, EXTENDED RELEASE;ORAL36MGYesNo
006AUSTEDO XRDEUTETRABENAZINETABLET, EXTENDED RELEASE;ORAL42MGYesNo
007AUSTEDO XRDEUTETRABENAZINETABLET, EXTENDED RELEASE;ORAL48MGYesYes
008AUSTEDO XRDEUTETRABENAZINETABLET, EXTENDED RELEASE;ORAL18MGYesNo

Documents

DocumentSubmission typeDate
82376SUPPL 2025-06-02
81411SUPPL 2025-03-03
81410SUPPL 2025-03-03
78985SUPPL 2024-07-08
78963SUPPL 2024-07-02
78780SUPPL 2024-05-31
78582SUPPL 2024-05-30
77303ORIG 2024-01-26
73579ORIG 2023-02-21
73559ORIG 2023-02-17