Application 215244

Type
NDA
Sponsor
STEALTH BIOTHERAPS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FORZINITYELAMIPRETIDE HYDROCHLORIDESOLUTION;SUBCUTANEOUSEQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83630ORIG 2025-10-02
83415ORIG 2025-09-23
83406ORIG 2025-09-19