Glutamine Oral Solution

Brand(s): Nutrestore
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Emmaus Medical, Inc. (2014-07-15)
Oldest Current Product: 2008-06-04
License(s): NDA

RxNORM: ORAL SOLUTION\GLUTAMINE
FDAOB: ORAL\FOR SOLUTION\GLUTAMINE
SPL Active: ORAL\POWDER, FOR SOLUTION\GLUTAMINE
SPL Moiety: ORAL\POWDER, FOR SOLUTION\GLUTAMINE

product(s) by strength(s)

glutamine 20.8 mg/ml oral solution

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	424570001	Nutrestore	NDA	Emmaus Medical, Inc.	2008-06-04	GLUTAMINE	ORAL	POWDER, FOR SOLUTION	NDA021667	cd3fb572-c5b1-43da-aea2-31208985f544

application(s)

#	id	title	applicant	approved	approved drug
1	NDA021667	NUTRESTORE	EMMAUS MEDICAL INC	2004-06-10	NDA021667_001

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	NDA021667_001	RX	GLUTAMINE (5GM/PACKET)	ORAL	FOR SOLUTION	True	2004-06-10	NUTRESTORE

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	cd3fb572-c5b1-43da-aea2-31208985f544 (view SPL)	These highlights do not include all the information needed to use NUTRESTORE safely and effectively. See full prescribing information for NUTRESTORE. NUTRESTORE [L-glutamine powder for oral solution] Initial U.S. Approval: 2004	prescription	Human Prescription	Emmaus Medical, Inc.	API MANUFACTURE, PACK	2014-07-15	2	424570001

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