FDA.reportPublic FDA data

Application 761451

Type
BLA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAPHNELOANIFROLIMAB-FNIAVIAL; SINGLE-USE300MG/2ML (150MG/MLNoNo
002SAPHNELOANIFROLIMAB-FNIAINJECTION120MG/0.8MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85774ORIG 2026-04-28
85772ORIG 2026-04-27