mivacurium Injectable Solution

Brand(s): Mivacron
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Abbvie Inc. (2015-01-30)
Oldest Current Product: 2015-01-30
License(s): NDA

RxNORM: INJECTABLE SOLUTION\MIVACURIUM
FDAOB: INJECTION\INJECTION\MIVACURIUM CHLORIDE\rdfq
INTRAVENOUS\SOLUTION\MIVACURIUM CHLORIDE
SPL Active: INTRAVENOUS\SOLUTION\MIVACURIUM CHLORIDE
SPL Moiety: INTRAVENOUS\SOLUTION\MIVACURIUM

product(s) by strength(s)

mivacurium 2 mg/ml injectable solution

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000744365	Mivacron	NDA	Abbvie Inc.	2015-01-30	MIVACURIUM CHLORIDE	INTRAVENOUS	SOLUTION	NDA020098	916b8d1f-3f91-40fb-ab33-13069523c36d

application(s)

#	id	title	deprecated	applicant	approved	approved drug
1	ANDA078562	MIVACURIUM CHLORIDE	True	MYLAN LABORATORIES LTD	2009-04-30	ANDA078562_001
2	NDA020098	MIVACRON		ABBVIE INC	1992-01-22	NDA020098_001, NDA020098_002, NDA020098_003, NDA020098_004, NDA020098_005

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	ANDA078562_001	discontinued	MIVACURIUM CHLORIDE (EQ 2MG BASE/ML)		INJECTION	False	2009-04-30	MIVACURIUM CHLORIDE
2	NDA020098_001	discontinued	MIVACURIUM CHLORIDE (EQ 2MG BASE/ML)	INTRAVENOUS	SOLUTION	False	1992-01-22	MIVACRON
3	NDA020098_002	discontinued	MIVACURIUM CHLORIDE (EQ 0.5MG BASE/ML)		INJECTION	False	1992-01-22	MIVACRON
4	NDA020098_003	discontinued	MIVACURIUM CHLORIDE (EQ 50MG BASE/100ML)		INJECTION	False	1992-01-22	MIVACRON
5	NDA020098_004	RX	MIVACURIUM CHLORIDE (EQ 10MG BASE/5ML)	INTRAVENOUS	SOLUTION	False	1992-01-22	MIVACRON
6	NDA020098_005	RX	MIVACURIUM CHLORIDE (EQ 20MG BASE/10ML)	INTRAVENOUS	SOLUTION	True	1992-01-22	MIVACRON

spl(s)

#	id	title	category	type	labeler	last update	version	product(s)
1	916b8d1f-3f91-40fb-ab33-13069523c36d (view SPL)	MIVACRON Injection(mivacurium chloride)	prescription	Human Prescription	Abbvie Inc.	2015-01-30	1419	000744365

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII