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 | 2026-08-01 |
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 |
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 ยท 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 |