Application 218160

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETEVMOSELPERCATINIBTABLET;ORAL40MGYesNo
002RETEVMOSELPERCATINIBTABLET;ORAL80MGYesNo
003RETEVMOSELPERCATINIBTABLET;ORAL120MGYesNo
004RETEVMOSELPERCATINIBTABLET;ORAL160MGYesYes
005RETEVMOSELPERCATINIBCAPSULE;ORAL40MGNoNo
006RETEVMOSELPERCATINIBCAPSULE;ORAL80MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84267SUPPL 2025-11-21
84266SUPPL 2025-11-21
84262SUPPL 2025-11-21
84261SUPPL 2025-11-21
81773ORIG 2025-03-28
80646SUPPL 2024-12-19
80639SUPPL 2024-12-19
79767SUPPL 2024-09-30
79766SUPPL 2024-09-30
79760SUPPL 2024-09-30
79759SUPPL 2024-09-30
78786SUPPL 2024-06-13
78778SUPPL 2024-06-12
78113ORIG 2024-04-12
78105ORIG 2024-04-10