Application 218785

Type
NDA
Sponsor
BEONE MEDICINES USA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001BRUKINSAZANUBRUTINIBTABLET;ORAL160MGYesYes
002BRUKINSAZANUBRUTINIBCAPSULE; ORAL80MGNoNo

Documents

DocumentSubmission typeDate
82552ORIG 2025-06-12
82550ORIG 2025-06-12
82540ORIG 2025-06-11
82539ORIG 2025-06-11