Application 216099

Type
NDA
Sponsor
HANDA THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHYRAGODASATINIBTABLET;ORAL20MGYesNo
002PHYRAGODASATINIBTABLET;ORAL50MGYesNo
003PHYRAGODASATINIBTABLET;ORAL70MGYesNo
004PHYRAGODASATINIBTABLET;ORAL80MGYesNo
005PHYRAGODASATINIBTABLET;ORAL100MGYesYes
006PHYRAGODASATINIBTABLET;ORAL140MGYesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83050SUPPL 2025-08-05
83038SUPPL 2025-08-04
80524SUPPL 2024-12-05
80502SUPPL 2024-12-04
79744ORIG 2024-09-26
79283SUPPL 2024-08-02
79275SUPPL 2024-08-02
76742ORIG 2023-12-06
74316ORIG 2023-12-06