Home Applications 761085 Application 761085
Type BLA
Sponsor EVOLUS INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761085 Jeuveau prabotulinumtoxinA-xvfs 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JEUVEAU PRABOTULINUMTOXINA-XVFS INJECTABLE;INJECTION 100 UNITS 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 Jeuveau PRABOTULINUM TOXIN TYPE A Evolus, Inc. 17a914c1-e54b-4b50-965d-b0fd9111bba4 2023-04-28 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761085 ndc (product): 72301-595
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 72301-595 Jeuveau Prabotulinum Toxin Type A Evolus, Inc. BLA Current 72301-595 Jeuveau Prabotulinum Toxin Type A Evolus, Inc. BLA Current 72301-595 Jeuveau Prabotulinum Toxin Type A Evolus, Inc. BLA Current 72301-595 Jeuveau Prabotulinum Toxin Type A Evolus, Inc. BLA Current 72301-595 Jeuveau Prabotulinum Toxin Type A Evolus, Inc. BLA Current 72301-595 Jeuveau Prabotulinum Toxin Type A Evolus, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 59335 SUPPL 2019-07-15 59330 SUPPL 2019-07-15 57907 ORIG 2019-03-05 57551 ORIG 2019-02-13 57414 ORIG 2019-02-04 57411 ORIG 2019-02-04