Cefuroxime Oral Suspension

Brand(s)
Ceftin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2015-07-08)
Oldest Current Product
2004-06-02
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\CEFUROXIME
FDAOB
ORAL\FOR SUSPENSION\CEFUROXIME AXETIL
SPL Active
ORAL\POWDER, FOR SUSPENSION\CEFUROXIME AXETIL
ORAL\SUSPENSION\CEFUROXIME AXETIL
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\CEFUROXIME
ORAL\SUSPENSION\CEFUROXIME

product(s) by strength(s)

cefuroxime 25 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730740CeftinNDAGlaxosmithkline Llc2004-06-02CEFUROXIME AXETILORALPOWDER, FOR SUSPENSIONNDA0506722f439b86-59d6-4350-aeb4-c904b3781db4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633040963ANDARnabaxy Pharmaceuticals Inc.2008-02-08CEFUROXIME AXETILORALSUSPENSIONANDA065323135e2dfc-eb47-4d04-a903-a081d36c267e

cefuroxime 50 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730741CeftinNDAGlaxosmithkline Llc2004-06-02CEFUROXIME AXETILORALPOWDER, FOR SUSPENSIONNDA0506722f439b86-59d6-4350-aeb4-c904b3781db4

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545694737CeftinNDAA-S Medication Solutions Llc2004-06-02CEFUROXIME AXETILORALPOWDER, FOR SUSPENSION001730741NDA050672376bb7f3-b938-4f80-9f68-f44bb88a3894

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA065323CEFUROXIME AXETILSUN PHARMACEUTICAL INDUSTRIES LTD2008-02-05ANDA065323_001, ANDA065323_002
2NDA050672CEFTINGLAXOSMITHKLINE1994-06-30NDA050672_001, NDA050672_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065323_001RXCEFUROXIME AXETIL (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2008-02-05CEFUROXIME AXETIL
2ANDA065323_002RXCEFUROXIME AXETIL (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2008-02-05CEFUROXIME AXETIL
3NDA050672_001RXCEFUROXIME AXETIL (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAB1994-06-30CEFTIN
4NDA050672_002RXCEFUROXIME AXETIL (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONTrueAB1997-04-29CEFTIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1135e2dfc-eb47-4d04-a903-a081d36c267e (view SPL)CEFUROXIME AXETIL FOR ORAL SUSPENSION,USPRx OnlyprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.manufacture2013-08-191633040963, 633040964
22f439b86-59d6-4350-aeb4-c904b3781db4 (view SPL)These highlights do not include all the information needed to use CEFTIN safely and effectively. See full prescribing information for CEFTIN.CEFTIN (cefuroxime axetil) tablets, for oral useCEFTIN (cefuroxime axetil), for oral suspensionInitial U.S. Approval: 1987prescriptionHuman PrescriptionGlaxosmithkline Llc2015-07-0811001730740, 001730741, 001730387, 001730394Cefuroxime Oral Tablet
3376bb7f3-b938-4f80-9f68-f44bb88a3894 (view SPL)CEFTIN Tablets ( cefuroxime axetil tablets) CEFTIN for Oral Suspension ( cefuroxime axetil powder for oral suspension)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-201545694737

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