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)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1424570001NutrestoreNDAEmmaus Medical, Inc.2008-06-04GLUTAMINEORALPOWDER, FOR SOLUTIONNDA021667cd3fb572-c5b1-43da-aea2-31208985f544

application(s)

#idtitleapplicantapprovedapproved drug
1NDA021667NUTRESTOREEMMAUS MEDICAL INC2004-06-10NDA021667_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021667_001RXGLUTAMINE (5GM/PACKET)ORALFOR SOLUTIONTrue2004-06-10NUTRESTORE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1cd3fb572-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: 2004prescriptionHuman PrescriptionEmmaus Medical, Inc.API MANUFACTURE, PACK2014-07-152424570001

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