Home Applications 761063 Application 761063
Type BLA
Sponsor ELI LILLY AND CO Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761063 Emgality galcanezumab-gnlm 351(a) Rx 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMGALITY GALCANEZUMAB-GNLM 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-1436 EMGALITY galcanezumab-gnlm Eli Lilly and Company BLA Current 0002-1436 EMGALITY galcanezumab Eli Lilly and Company BLA Current 0002-1436 EMGALITY galcanezumab Eli Lilly and Company BLA Current 0002-1436 EMGALITY galcanezumab-gnlm Eli Lilly and Company BLA Current 0002-1436 EMGALITY galcanezumab Eli Lilly and Company BLA Current 0002-1436 EMGALITY galcanezumab Eli Lilly and Company BLA Current 0002-2377 EMGALITY galcanezumab-gnlm Eli Lilly and Company BLA Current 0002-2377 EMGALITY galcanezumab Eli Lilly and Company BLA Current 0002-2377 EMGALITY galcanezumab Eli Lilly and Company BLA Current 0002-2377 EMGALITY galcanezumab-gnlm Eli Lilly and Company BLA Current 0002-2377 EMGALITY galcanezumab Eli Lilly and Company BLA Current 0002-2377 EMGALITY galcanezumab Eli Lilly and Company BLA Current 0002-3115 EMGALITY galcanezumab-gnlm Eli Lilly and Company BLA Current 0002-3115 EMGALITY galcanezumab Eli Lilly and Company BLA Current 0002-3115 EMGALITY galcanezumab-gnlm Eli Lilly and Company BLA Current 0002-3115 EMGALITY galcanezumab Eli Lilly and Company BLA Current 0002-3115 EMGALITY galcanezumab Eli Lilly and Company BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 81719 SUPPL 2025-03-25 81696 SUPPL 2025-03-24 71149 SUPPL 2022-05-26 71148 SUPPL 2022-05-25 61186 SUPPL 2019-12-06 61171 SUPPL 2019-12-06 58974 SUPPL 2019-06-05 58971 SUPPL 2019-06-05 56323 ORIG 2018-11-07 55761 ORIG 2018-10-01 55641 ORIG 2018-09-28