cefpodoxime Oral Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2014-02-12)
Oldest Current Product
2007-06-08
License(s)
ANDA
RxNORM
ORAL SUSPENSION\CEFPODOXIME
FDAOB
ORAL\FOR SUSPENSION\CEFPODOXIME PROXETIL
SPL Active
ORAL\GRANULE, FOR SUSPENSION\CEFPODOXIME PROXETIL
SPL Moiety
ORAL\GRANULE, FOR SUSPENSION\CEFPODOXIME

product(s) by strength(s)

cefpodoxime 10 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007816168ANDASandoz Inc2009-06-25CEFPODOXIME PROXETILORALGRANULE, FOR SUSPENSIONANDA09003106a35453-8356-4690-aacb-3845cdc84102
2167140402ANDANorthstar Rx Llc2007-06-08CEFPODOXIME PROXETILORALGRANULE, FOR SUSPENSIONANDA0654095310de78-22c3-4bee-9956-854e767b6bef
3658620140ANDAAurobindo Pharma Limited2007-06-08CEFPODOXIME PROXETILORALGRANULE, FOR SUSPENSIONANDA06540963777889-d306-4fc3-88da-b24859040ef4

cefpodoxime 20 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007816169ANDASandoz Inc2009-06-25CEFPODOXIME PROXETILORALGRANULE, FOR SUSPENSIONANDA09003106a35453-8356-4690-aacb-3845cdc84102
2167140403ANDANorthstar Rx Llc2007-06-08CEFPODOXIME PROXETILORALGRANULE, FOR SUSPENSIONANDA0654095310de78-22c3-4bee-9956-854e767b6bef
3658620141ANDAAurobindo Pharma Limited2007-06-08CEFPODOXIME PROXETILORALGRANULE, FOR SUSPENSIONANDA06540963777889-d306-4fc3-88da-b24859040ef4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065082CEFPODOXIME PROXETILSUN PHARMACEUTICAL INDUSTRIES LTD2002-05-31ANDA065082_001, ANDA065082_002
2ANDA065409CEFPODOXIME PROXETILAUROBINDO PHARMA LTD2007-06-08ANDA065409_001, ANDA065409_002
3ANDA090031CEFPODOXIME PROXETILSANDOZ INC2009-01-14ANDA090031_001, ANDA090031_002
4NDA050675VANTINTruePHARMACIA AND UPJOHN CO1992-08-07NDA050675_001, NDA050675_002
5NDA050688BANANTrueSANKYO USA CORP1992-08-07NDA050688_001, NDA050688_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065082_001RXCEFPODOXIME PROXETIL (EQ 50MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2002-05-31CEFPODOXIME PROXETIL
2ANDA065082_002RXCEFPODOXIME PROXETIL (EQ 100MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2002-05-31CEFPODOXIME PROXETIL
3ANDA065409_001RXCEFPODOXIME PROXETIL (EQ 50MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2007-06-08CEFPODOXIME PROXETIL
4ANDA065409_002RXCEFPODOXIME PROXETIL (EQ 100MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2007-06-08CEFPODOXIME PROXETIL
5ANDA090031_001RXCEFPODOXIME PROXETIL (EQ 50MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2009-01-14CEFPODOXIME PROXETIL
6ANDA090031_002RXCEFPODOXIME PROXETIL (EQ 100MG BASE/5ML)ORALFOR SUSPENSIONTrueAB2009-01-14CEFPODOXIME PROXETIL
7NDA050675_001discontinuedCEFPODOXIME PROXETIL (EQ 50MG BASE/5ML)ORALFOR SUSPENSIONFalse1992-08-07VANTIN
8NDA050675_002discontinuedCEFPODOXIME PROXETIL (EQ 100MG BASE/5ML)ORALFOR SUSPENSIONFalse1992-08-07VANTIN
9NDA050688_001discontinuedCEFPODOXIME PROXETIL (EQ 100MG BASE/5ML)ORALFOR SUSPENSIONFalse1992-08-07BANAN
10NDA050688_002discontinuedCEFPODOXIME PROXETIL (EQ 50MG BASE/5ML)ORALFOR SUSPENSIONFalse1992-08-07BANAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
106a35453-8356-4690-aacb-3845cdc84102 (view SPL)Cefpodoxime Proxetil for Oral Suspension, USPprescriptionHuman PrescriptionSandoz Inc2014-02-1215007816168, 007816169
25310de78-22c3-4bee-9956-854e767b6bef (view SPL)prescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2013-12-032167140402, 167140403
363777889-d306-4fc3-88da-b24859040ef4 (view SPL)Cefpodoxime Proxetil for Oral Suspension, USP Rx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-04-086658620140, 658620141

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