Application 219249

Type
NDA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ITOVEBIINAVOLISIBTABLET;ORAL3MGYesNo
002ITOVEBIINAVOLISIBTABLET;ORAL9MGYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85705SUPPL 2026-04-17
85696SUPPL 2026-04-16
83545SUPPL 2025-09-26
83559SUPPL 2025-09-25
80169ORIG 2024-11-05
79894ORIG 2024-10-15
79857ORIG 2024-10-11