deferiprone Oral Solution

Brand(s): Ferriprox
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Apo-Pharma Usa, Inc (2015-09-15)
Oldest Current Product: 2015-09-09
License(s): NDA

RxNORM: ORAL SOLUTION\DEFERIPRONE
FDAOB: ORAL\SOLUTION\DEFERIPRONE
SPL Active: ORAL\SOLUTION\DEFERIPRONE
SPL Moiety: ORAL\SOLUTION\DEFERIPRONE

product(s) by strength(s)

deferiprone 100 mg/ml oral solution

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	526094502	Ferriprox	NDA	Apo-Pharma Usa, Inc	2015-09-09	DEFERIPRONE	ORAL	SOLUTION	NDA208030	97f7bfcb-8666-464c-87b6-9621ceca5ee2

application(s)

#	id	title	applicant	approved	patent	exclusivity	approved drug
1	NDA208030	FERRIPROX	APOPHARMA INC	2015-09-09	p8703156, METHOD OF TREATING CHRONIC IRON OVERLOAD, SUBSTANCE p7049328, METHOD OF TREATING CHRONIC IRON OVERLOAD	NEW CHEMICAL ENTITY [2016-10-14] ORPHAN DRUG EXCLUSIVITY [2016-10-14]	NDA208030_001

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	NDA208030_001	RX	DEFERIPRONE (100MG/ML)	ORAL	SOLUTION	True	2015-09-09	FERRIPROX

patent(s)

#	id	expiration date	application(s)	in other drug docs
1	p7049328 (view patent)	2021-06-28	NDA208030, NDA021825	deferiprone Oral Tablet
2	p8703156 (view patent)	2029-10-29	NDA208030

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	97f7bfcb-8666-464c-87b6-9621ceca5ee2 (view SPL)	These highlights do not include all the information needed to use FERRIPROX safely and effectively. See full prescribing information for FERRIPROX. FERRIPROX (deferiprone) oral solution, for oral useInitial U.S. Approval: 2011	prescription	Human Prescription	Apo-Pharma Usa, Inc	analysis, manufacture	2015-09-15	9	526094502

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