cefpodoxime Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2014-07-28)
Oldest Current Product
2007-06-11
License(s)
ANDA
RxNORM
ORAL TABLET\CEFPODOXIME
FDAOB
ORAL\TABLET\CEFPODOXIME PROXETIL
SPL Active
ORAL\TABLET, FILM COATED\CEFPODOXIME PROXETIL
SPL Moiety
ORAL\TABLET, FILM COATED\CEFPODOXIME

product(s) by strength(s)

cefpodoxime 100 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007815438ANDASandoz Inc2008-05-28CEFPODOXIME PROXETILORALTABLET, FILM COATEDANDA0654628519a9d8-7106-4545-bc58-859ee9a6708e
2167140394ANDANorthstar Rx Llc2007-06-11CEFPODOXIME PROXETILORALTABLET, FILM COATEDANDA0653704587a7c1-cd6c-4946-a0dd-fcfe0c8504b9
3266370711ANDAPutney, Inc.2008-05-28CEFPODOXIME PROXETILORALTABLET, FILM COATEDANDA06546291f2a366-97f3-4372-9803-f0e8afe89089
4523430019ANDALucid Pharma Llc2007-06-11CEFPODOXIME PROXETILORALTABLET, FILM COATEDANDA0653706a0f198d-3e66-4363-8c63-289048e2c5b8
5658620095ANDAAurobindo Pharma Limited2007-06-11CEFPODOXIME PROXETILORALTABLET, FILM COATEDANDA065370c36f2137-98bb-4583-89f7-6bce9582c465

cefpodoxime 200 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007815439ANDASandoz Inc2008-05-28CEFPODOXIME PROXETILORALTABLET, FILM COATEDANDA0654628519a9d8-7106-4545-bc58-859ee9a6708e
2167140395ANDANorthstar Rx Llc2007-06-11CEFPODOXIME PROXETILORALTABLET, FILM COATEDANDA0653704587a7c1-cd6c-4946-a0dd-fcfe0c8504b9
3266370712ANDAPutney, Inc.2008-05-28CEFPODOXIME PROXETILORALTABLET, FILM COATEDANDA06546291f2a366-97f3-4372-9803-f0e8afe89089
4523430020ANDALucid Pharma Llc2007-06-11CEFPODOXIME PROXETILORALTABLET, FILM COATEDANDA0653706a0f198d-3e66-4363-8c63-289048e2c5b8
5658620096ANDAAurobindo Pharma Limited2007-06-11CEFPODOXIME PROXETILORALTABLET, FILM COATEDANDA065370c36f2137-98bb-4583-89f7-6bce9582c465

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1552890393ANDAPd-Rx Pharmaceuticals, Inc.2007-06-11CEFPODOXIME PROXETILORALTABLET, FILM COATED658620096ANDA0653708b7f7043-5bfb-47a5-80cb-4f3f65358dff

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065083CEFPODOXIME PROXETILSUN PHARMACEUTICAL INDUSTRIES LTD2003-08-20ANDA065083_001, ANDA065083_002
2ANDA065370CEFPODOXIME PROXETILAUROBINDO PHARMA LTD2007-06-11ANDA065370_001, ANDA065370_002
3ANDA065388CEFPODOXIME PROXETILORCHID HEALTHCARE2007-11-14ANDA065388_001, ANDA065388_002
4ANDA065462CEFPODOXIME PROXETILSANDOZ INC2008-05-28ANDA065462_001, ANDA065462_002
5NDA050674VANTINTruePHARMACIA AND UPJOHN CO1992-08-07NDA050674_001, NDA050674_002
6NDA050687BANANTrueSANKYO USA CORP1992-08-07NDA050687_001, NDA050687_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065083_001RXCEFPODOXIME PROXETIL (EQ 100MG BASE)ORALTABLETFalseAB2003-08-20CEFPODOXIME PROXETIL
2ANDA065083_002RXCEFPODOXIME PROXETIL (EQ 200MG BASE)ORALTABLETFalseAB2003-08-20CEFPODOXIME PROXETIL
3ANDA065370_001RXCEFPODOXIME PROXETIL (EQ 100MG BASE)ORALTABLETFalseAB2007-06-11CEFPODOXIME PROXETIL
4ANDA065370_002RXCEFPODOXIME PROXETIL (EQ 200MG BASE)ORALTABLETFalseAB2007-06-11CEFPODOXIME PROXETIL
5ANDA065388_001RXCEFPODOXIME PROXETIL (EQ 100MG BASE)ORALTABLETFalseAB2007-11-14CEFPODOXIME PROXETIL
6ANDA065388_002RXCEFPODOXIME PROXETIL (EQ 200MG BASE)ORALTABLETFalseAB2007-11-14CEFPODOXIME PROXETIL
7ANDA065462_001RXCEFPODOXIME PROXETIL (EQ 100MG BASE)ORALTABLETFalseAB2008-05-28CEFPODOXIME PROXETIL
8ANDA065462_002RXCEFPODOXIME PROXETIL (EQ 200MG BASE)ORALTABLETTrueAB2008-05-28CEFPODOXIME PROXETIL
9NDA050674_001discontinuedCEFPODOXIME PROXETIL (EQ 100MG BASE)ORALTABLETFalse1992-08-07VANTIN
10NDA050674_002discontinuedCEFPODOXIME PROXETIL (EQ 200MG BASE)ORALTABLETFalse1992-08-07VANTIN
11NDA050687_001discontinuedCEFPODOXIME PROXETIL (EQ 100MG BASE)ORALTABLETFalse1992-08-07BANAN
12NDA050687_002discontinuedCEFPODOXIME PROXETIL (EQ 200MG BASE)ORALTABLETFalse1992-08-07BANAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14587a7c1-cd6c-4946-a0dd-fcfe0c8504b9 (view SPL)prescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2013-10-012167140394, 167140395
26a0f198d-3e66-4363-8c63-289048e2c5b8 (view SPL)Cefpodoxime Proxetil Tablets, USPRx onlyprescriptionHuman PrescriptionLucid Pharma Llc2014-04-083523430019, 523430020
38519a9d8-7106-4545-bc58-859ee9a6708e (view SPL)Cefpodoxime Proxetil Tablets, USPprescriptionHuman PrescriptionSandoz Inc2014-07-2814007815438, 007815439
48b7f7043-5bfb-47a5-80cb-4f3f65358dff (view SPL)Cefpodoxime Proxetil Tablets, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-06-233552890393
591f2a366-97f3-4372-9803-f0e8afe89089 (view SPL)Cefpodoxime Proxetil Tablets, USPprescriptionHuman PrescriptionPutney, Inc.2014-09-2312266370711, 266370712
6c36f2137-98bb-4583-89f7-6bce9582c465 (view SPL)Cefpodoxime Proxetil Tablets, USPprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2013-07-305658620095, 658620096

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