Application 219713

Type
NDA
Sponsor
NUVATION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBTROZITALETRECTINIB ADIPATECAPSULE;ORALEQ 200MG BASEYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82724ORIG 2025-07-02
82557ORIG 2025-06-12
82556ORIG 2025-06-12