Application 214759

Type
NDA
Sponsor
MEDEXUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRAFAPEXTREOSULFANPOWDER;INTRAVENOUS1GM/VIALYesYes
002GRAFAPEXTREOSULFANPOWDER;INTRAVENOUS5GM/VIALYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81308ORIG 2025-02-21
81121SUPPL 2025-02-07
81098SUPPL 2025-02-06
80915ORIG 2025-02-04
80904ORIG 2025-02-04