Application 218197

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRUQAPCAPIVASERTIBTABLET;ORAL160MGYesNo
002TRUQAPCAPIVASERTIBTABLET;ORAL200MGYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84183SUPPL 2025-11-18
84175SUPPL 2025-11-17
81263SUPPL 2025-02-18
81258SUPPL 2025-02-14
79729SUPPL 2024-09-24
79709SUPPL 2024-09-24
76873ORIG 2023-12-15
76619ORIG 2023-11-17
76598ORIG 2023-11-17