Home Applications 761136 Application 761136
Type BLA
Sponsor CELGENE CORP Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761136 Reblozyl luspatercept-aamt 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REBLOZYL LUSPATERCEPT-AAMT POWDER;SUBCUTANEOUS 25MG/VIAL No No 002 REBLOZYL LUSPATERCEPT-AAMT POWDER;SUBCUTANEOUS 75MG/VIAL 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 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59572-711 Luspatercept Luspatercept Celgene BLA Current 59572-711 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-711 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-711 Reblozyl Luspatercept Celgene BLA Current 59572-711 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-711 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-711 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-711 Reblozyl Luspatercept Celgene BLA Current 59572-711 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-711 Reblozyl Luspatercept Celgene BLA Current 59572-775 Luspatercept Luspatercept Celgene BLA Current 59572-775 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-775 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-775 Reblozyl Luspatercept Celgene BLA Current 59572-775 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-775 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-775 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-775 Reblozyl Luspatercept Celgene BLA Current 59572-775 Reblozyl Luspatercept Celgene Corporation BLA Current 59572-775 Reblozyl Luspatercept Celgene BLA Current