FDA.reportPublic FDA data

Application 217639

Type
NDA
Sponsor
STEMLINE THERAPEUTICS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORSERDUELACESTRANTTABLET;ORAL345MGNoNo
002ORSERDUELACESTRANTTABLET;ORAL86MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85110ORIG 2026-02-24
76609SUPPL 2026-02-24
76565SUPPL 2023-11-14
73639ORIG 2023-03-01
73328ORIG2023-01-30
73305ORIG2023-01-30