remifentanil Injectable Solution

Brand(s): Ultiva
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Mylan Institutional Llc (2013-12-31)
Oldest Current Product: 1996-11-06
License(s): NDA

RxNORM: INJECTABLE SOLUTION\REMIFENTANIL
FDAOB: INJECTION\INJECTION\REMIFENTANIL HYDROCHLORIDE\rdfq
SPL Active: INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\REMIFENTANIL HYDROCHLORIDE
SPL Moiety: INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\REMIFENTANIL

product(s) by strength(s)

remifentanil 1 mg/ml injectable solution

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	674570198	Ultiva	NDA	Mylan Institutional Llc	1996-11-06	REMIFENTANIL HYDROCHLORIDE	INTRAVENOUS	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	NDA020630	dbc63b6e-f8c5-4fd0-8ec3-4f5e19125313

application(s)

#	id	title	applicant	approved	patent	approved drug
1	NDA020630	ULTIVA	MYLAN INSTITUTIONAL LLC	1996-07-12	p5866591, SUBSTANCE	NDA020630_001, NDA020630_002, NDA020630_003

application drug(s)

#	id	category/deprecated	ingredient strength(s)	dose form	rld	approved	application
1	NDA020630_001	RX	REMIFENTANIL HYDROCHLORIDE (EQ 1MG BASE/VIAL)	INJECTION	False	1996-07-12	ULTIVA
2	NDA020630_002	RX	REMIFENTANIL HYDROCHLORIDE (EQ 2MG BASE/VIAL)	INJECTION	False	1996-07-12	ULTIVA
3	NDA020630_003	RX	REMIFENTANIL HYDROCHLORIDE (EQ 5MG BASE/VIAL)	INJECTION	True	1996-07-12	ULTIVA

patent(s)

#	id	expiration date	application(s)
1	p5866591 (view patent)	2017-09-10	NDA020630

spl(s)

#	id	title	category	type	labeler	last update	version	product(s)
1	dbc63b6e-f8c5-4fd0-8ec3-4f5e19125313 (view SPL)		prescription	Human Prescription	Mylan Institutional Llc	2013-12-31	5	674570198

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