Cefadroxil Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2014-09-03)
Oldest Current Product
2006-03-30
License(s)
ANDA
RxNORM
ORAL TABLET\CEFADROXIL
FDAOB
ORAL\TABLET\CEFADROXIL/CEFADROXIL HEMIHYDRATE
SPL Active
ORAL\TABLET, FILM COATED\CEFADROXIL
ORAL\TABLET\CEFADROXIL
SPL Moiety
ORAL\TABLET, FILM COATED\CEFADROXIL ANHYDROUS
ORAL\TABLET\CEFADROXIL ANHYDROUS

product(s) by strength(s)

cefadroxil 1000 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934059ANDATeva Pharmaceuticals Usa Inc2007-01-31CEFADROXILORALTABLETANDA0627744674a05c-fdef-4737-a4b8-e3229bdada9d
2001439948ANDAWest-Ward Pharmaceutical Corp2006-03-30CEFADROXILORALTABLET, FILM COATEDANDA0652602ec9ad88-f13c-406d-ac02-a77cf0de6963

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062390ULTRACEFTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1982-06-10ANDA062390_001
2ANDA062408ULTRACEFTrueBRISTOL LABORATORIES INC DIV BRISTOL MYERS CO1982-08-31ANDA062408_001
3ANDA062774CEFADROXILTEVA PHARMACEUTICALS USA1987-04-08ANDA062774_001
4ANDA065018CEFADROXILTrueRANBAXY PHARMACEUTICALS INC1999-04-23ANDA065018_001
5ANDA065260CEFADROXILHIKMA PHARMACEUTICALS2006-03-30ANDA065260_001
6ANDA065301CEFADROXILORCHID HEALTHCARE2006-09-18ANDA065301_001
7NDA050528DURICEFTrueWARNER CHILCOTT INCNDA050528_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062390_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 1GM BASE)ORALTABLETFalse1982-06-10ULTRACEF
2ANDA062408_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 1GM BASE)ORALTABLETFalse1982-08-31ULTRACEF
3ANDA062774_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 1GM BASE)ORALTABLETTrue1987-04-08CEFADROXIL
4ANDA065018_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 1GM BASE)ORALTABLETFalse1999-04-23CEFADROXIL
5ANDA065260_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 1GM BASE)ORALTABLETFalseAB2006-03-30CEFADROXIL
6ANDA065301_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 1GM BASE)ORALTABLETFalseAB2006-09-18CEFADROXIL
7NDA050528_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 1GM BASE)ORALTABLETFalseDURICEF

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
12ec9ad88-f13c-406d-ac02-a77cf0de6963 (view SPL)Cefadroxil Tablets, USP Rev. 03/14 Rx OnlyprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2014-09-252001439948
24674a05c-fdef-4737-a4b8-e3229bdada9d (view SPL)CEFADROXIL TABLETS USP4059Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-09-034000934059

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