Application 219208

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANRAFIAATRASENTAN HYDROCHLORIDETABLET;ORALEQ 0.75MG BASEYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83864SUPPL 2025-10-21
83863SUPPL 2025-10-21
81875ORIG 2025-10-21
81814ORIG 2025-10-21
82199ORIG 2025-05-19