Application 103846

Type: BLA
Sponsor: ELAN PHARM

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

NDC Listings For This Application#

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

Application 103846

Related Records#

Application Products#

NDC Listings For This Application#

Documents#