Application 219847

Type
NDA
Sponsor
AZURITY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARYNTALISDEXAMFETAMINE DIMESYLATESOLUTION;ORAL10MG/MLYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84589SUPPL 2025-12-29
84545SUPPL 2025-12-23
83303ORIG 2025-09-08
82590ORIG 2025-06-17
82586ORIG 2025-06-17
82585ORIG 2025-06-16