Home Applications 761149 Application 761149
Type BLA
Sponsor GENENTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761149 Enspryng satralizumab-mwge 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENSPRYNG SATRALIZUMAB INJECTABLE;INJECTION 120MG/ML No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-007 Enspryng Satralizumab Genentech Inc. BLA Current 50242-007 Enspryng Satralizumab Genentech Inc. BLA Current 50242-007 Enspryng Satralizumab Genentech Inc. BLA Current 50242-007 Enspryng Satralizumab Genentech Inc. BLA Current 50242-007 Enspryng Satralizumab Genentech Inc. BLA Current 50242-007 Enspryng Satralizumab Genentech Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 72085 SUPPL 2022-09-15 72080 SUPPL 2022-09-15 72079 SUPPL 2022-09-15 67440 SUPPL 2021-05-07 67398 SUPPL 2021-05-04 64565 ORIG 2020-09-11 64288 ORIG 2020-08-17 64283 ORIG 2020-08-17