Home Applications 103846 Application 103846
Type BLA
Sponsor ELAN PHARM Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103846 Myobloc rimabotulinumtoxinB 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MYOBLOC Botulinum Toxin Type B VIAL 5000IU/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 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10454-710 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-710 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-710 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-710 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-710 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-710 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-710 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-710 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-710 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-711 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-711 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-711 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-711 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-711 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-711 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-711 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-711 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-711 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-712 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-712 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-712 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-712 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-712 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-712 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-712 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-712 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current 10454-712 Myobloc rimabotulinumtoxinB Solstice Neurosciences, LLC BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 66736 SUPPL 2021-03-11 66733 SUPPL 2021-03-11 66732 SUPPL 2021-03-11 59797 SUPPL 2019-08-21 59796 SUPPL 2019-08-21 59784 SUPPL 2019-08-21 9488 SUPPL 2012-06-15 39729 SUPPL 2009-08-07 9487 SUPPL 2009-08-07 23945 ORIG 2008-08-12 43289 ORIG 2004-03-17 18671 ORIG 2004-03-17 9486 ORIG 2004-03-17