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 2026-06-01
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# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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