Application 218730

Type
NDA
Sponsor
VERTEX PHARMS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ALYFTREKDEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUMTABLET;ORAL50MG;20MG;EQ 4MG BASEYesNo
002ALYFTREKDEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUMTABLET;ORAL125MG;50MG;EQ 10MG BASEYesYes

Documents

DocumentSubmission typeDate
85606SUPPL 2026-03-31
85580SUPPL 2026-03-30
85579SUPPL 2026-03-30
85510SUPPL 2026-03-24
85480SUPPL 2026-03-24
85395SUPPL 2026-03-19
83560SUPPL 2025-09-26
81117ORIG 2025-02-07
80714ORIG 2024-12-26
80692ORIG 2024-12-20