Home Applications 761119 Application 761119
Type BLA
Sponsor Lundbeck Seattle BioPharmaceuticals, Inc. Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761119 Vyepti eptinezumab-jjmr 351(a) Rx 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VYEPTI EPTINEZUMAB-JJMR INJECTABLE;INJECTION 100MG/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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vyepti EPTINEZUMAB-JJMR Lundbeck Pharmaceuticals LLC 79065861-6aa5-4d1f-829f-3a6471286b36 2026-06-05 Warnings, Adverse reactions Exact identifier application number: BLA761119 ndc (product): 67386-130
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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67386-130 Vyepti eptinezumab-jjmr Lundbeck Pharmaceuticals LLC BLA Current 67386-130 Vyepti eptinezumab-jjmr Lundbeck Pharmaceuticals LLC BLA Current 67386-130 Vyepti eptinezumab-jjmr Lundbeck Pharmaceuticals LLC BLA Current 67386-130 Vyepti eptinezumab-jjmr Lundbeck Pharmaceuticals LLC BLA Current 67386-130 Vyepti eptinezumab-jjmr Lundbeck Pharmaceuticals LLC BLA Current 67386-130 Vyepti eptinezumab-jjmr Lundbeck Pharmaceuticals LLC BLA Current 67386-130 Vyepti eptinezumab-jjmr Lundbeck Pharmaceuticals LLC BLA Current 67386-130 Vyepti eptinezumab-jjmr Lundbeck Pharmaceuticals LLC BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 83908 SUPPL 2025-10-23 83899 SUPPL 2025-10-23 81724 SUPPL 2025-03-25 81723 SUPPL 2025-03-25 81701 SUPPL 2025-03-24 81700 SUPPL 2025-03-24 72469 SUPPL 2022-10-26 72454 SUPPL 2022-10-24 68805 SUPPL 2021-09-29 68796 SUPPL 2021-09-28 62234 ORIG 2020-03-23 61947 ORIG 2020-02-24 61944 ORIG 2020-02-24