Cefadroxil Oral Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lupin Pharmaceuticals, Inc. (2014-03-07)
Oldest Current Product
2005-08-30
License(s)
ANDA
RxNORM
ORAL SUSPENSION\CEFADROXIL
FDAOB
ORAL\FOR SUSPENSION\CEFADROXIL/CEFADROXIL HEMIHYDRATE
SPL Active
ORAL\POWDER, FOR SUSPENSION\CEFADROXIL
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\CEFADROXIL
ORAL\POWDER, FOR SUSPENSION\CEFADROXIL ANHYDROUS

product(s) by strength(s)

cefadroxil 100 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439766ANDAWest-Ward Pharmaceutical Corp2012-11-28CEFADROXILORALPOWDER, FOR SUSPENSIONANDA0910361662f7df-ce96-4d24-ae32-9a7f8833311d
2167140390ANDANorthstar Rx Llc2013-04-25CEFADROXILORALPOWDER, FOR SUSPENSIONANDA06534930bb3686-87b4-4676-9ff5-e20deb8bff9d
3572370098ANDACitron Pharma Llc2013-04-25CEFADROXILORALPOWDER, FOR SUSPENSIONANDA0653496e4111d3-f11b-403c-b340-b216022709df
4633040974ANDARnabaxy Pharmaceuticals Inc.2005-08-30CEFADROXILORALPOWDER, FOR SUSPENSIONANDA0651155fc4f89c-cf94-4e7a-bf31-d3d86a242efa
5658620084ANDAAurobindo Pharma Limited2013-04-25CEFADROXILORALPOWDER, FOR SUSPENSIONANDA065349776a8dbc-e68e-4732-acf4-0133dca0f54c

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934181ANDATeva Pharmaceuticals Usa Inc2010-02-02CEFADROXILORALPOWDER, FOR SUSPENSIONANDA0652789d421f13-579c-4096-aa4e-1f931cd1d95c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685694ANDAPhysicians Total Care, Inc.2007-05-16CEFADROXILORALPOWDER, FOR SUSPENSION633040974ANDA0651154306730b-e894-45ca-b4e9-3fe7f65b7b1d

cefadroxil 25 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633040972ANDARnabaxy Pharmaceuticals Inc.2005-08-30CEFADROXILORALPOWDER, FOR SUSPENSIONANDA0651155fc4f89c-cf94-4e7a-bf31-d3d86a242efa

cefadroxil 50 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439767ANDAWest-Ward Pharmaceutical Corp2012-11-28CEFADROXILORALPOWDER, FOR SUSPENSIONANDA0910361662f7df-ce96-4d24-ae32-9a7f8833311d
2167140389ANDANorthstar Rx Llc2013-04-25CEFADROXILORALPOWDER, FOR SUSPENSIONANDA06534930bb3686-87b4-4676-9ff5-e20deb8bff9d
3572370097ANDACitron Pharma Llc2013-04-25CEFADROXILORALPOWDER, FOR SUSPENSIONANDA0653496e4111d3-f11b-403c-b340-b216022709df
4633040973ANDARnabaxy Pharmaceuticals Inc.2005-08-30CEFADROXILORALPOWDER, FOR SUSPENSIONANDA0651155fc4f89c-cf94-4e7a-bf31-d3d86a242efa
5658620083ANDAAurobindo Pharma Limited2013-04-25CEFADROXILORALPOWDER, FOR SUSPENSIONANDA065349776a8dbc-e68e-4732-acf4-0133dca0f54c
6681800181ANDALupin Pharmaceuticals, Inc.2008-04-23CEFADROXILORALPOWDER, FOR SUSPENSIONANDA06539627009a05-4d2b-4618-be76-39f348240eda

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934180ANDATeva Pharmaceuticals Usa Inc2010-02-02CEFADROXILORALPOWDER, FOR SUSPENSIONANDA0652789d421f13-579c-4096-aa4e-1f931cd1d95c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685693ANDAPhysicians Total Care, Inc.2006-10-19CEFADROXILORALPOWDER, FOR SUSPENSION633040973ANDA0651154306730b-e894-45ca-b4e9-3fe7f65b7b1d

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062334CEFADROXILTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA062334_001, ANDA062334_002, ANDA062334_003
2ANDA062376ULTRACEFTrueBRISTOL LABORATORIES INC DIV BRISTOL MYERS CO1982-03-16ANDA062376_001, ANDA062376_002, ANDA062376_003
3ANDA062698CEFADROXILTrueANI PHARMACEUTICALS INC1989-03-01ANDA062698_001, ANDA062698_002, ANDA062698_003
4ANDA065115CEFADROXILSUN PHARMACEUTICAL INDUSTRIES LTD2003-03-26ANDA065115_001, ANDA065115_002, ANDA065115_003
5ANDA065278CEFADROXILTrueANI PHARMACEUTICALS INC2006-01-20ANDA065278_001, ANDA065278_002
6ANDA065307CEFADROXILORCHID HEALTHCARE2006-10-16ANDA065307_002, ANDA065307_003
7ANDA065349CEFADROXILAUROBINDO PHARMA LTD2013-04-25ANDA065349_001, ANDA065349_002
8ANDA065396CEFADROXILLUPIN LTD2008-02-21ANDA065396_001, ANDA065396_002
9ANDA091036CEFADROXILHIKMA PHARMACEUTICALS2012-11-28ANDA091036_001, ANDA091036_002
10NDA050527DURICEFTrueWARNER CHILCOTT INCNDA050527_001, NDA050527_002, NDA050527_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062334_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseCEFADROXIL
2ANDA062334_002discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseCEFADROXIL
3ANDA062334_003discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONFalseCEFADROXIL
4ANDA062376_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1982-03-16ULTRACEF
5ANDA062376_002discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1982-03-16ULTRACEF
6ANDA062376_003discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONFalse1982-03-16ULTRACEF
7ANDA062698_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1989-03-01CEFADROXIL
8ANDA062698_002discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1989-03-01CEFADROXIL
9ANDA062698_003discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONFalse1989-03-01CEFADROXIL
10ANDA065115_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse2003-03-26CEFADROXIL
11ANDA065115_002RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2003-03-26CEFADROXIL
12ANDA065115_003RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2003-03-26CEFADROXIL
13ANDA065278_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse2006-01-20CEFADROXIL
14ANDA065278_002discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONFalse2006-01-20CEFADROXIL
15ANDA065307_002RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2006-10-16CEFADROXIL
16ANDA065307_003RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2006-10-16CEFADROXIL
17ANDA065349_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2013-04-25CEFADROXIL
18ANDA065349_002RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2013-04-25CEFADROXIL
19ANDA065396_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2008-02-21CEFADROXIL
20ANDA065396_002RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONTrueAB2008-02-21CEFADROXIL
21ANDA091036_001RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2012-11-28CEFADROXIL
22ANDA091036_002RXCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2012-11-28CEFADROXIL
23NDA050527_001discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONFalseDURICEF
24NDA050527_002discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseDURICEF
25NDA050527_003discontinuedCEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseDURICEF

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11662f7df-ce96-4d24-ae32-9a7f8833311d (view SPL)CEFADROXIL for Oral suspension, USP 250 mg/5 mL and 500mg/5 mL Rev. 03/15 Rx onlyprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2015-03-013001439766, 001439767
227009a05-4d2b-4618-be76-39f348240eda (view SPL)Cefadroxil for Oral Suspension USP, 250 mg/5 mL and 500 mg/5 mLprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2014-03-073681800181
330bb3686-87b4-4676-9ff5-e20deb8bff9d (view SPL)Cefadroxil for Oral Suspension, USPRx onlyprescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-03-262167140389, 167140390
44306730b-e894-45ca-b4e9-3fe7f65b7b1d (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-05-111548685693, 548685694
55fc4f89c-cf94-4e7a-bf31-d3d86a242efa (view SPL)CEFADROXIL FOR ORAL SUSPENSION, USPRx onlyprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.manufacture2013-08-142633040972, 633040973, 633040974
66e4111d3-f11b-403c-b340-b216022709df (view SPL)Cefadroxil for Oral Suspension, USPRx onlyprescriptionHuman PrescriptionCitron Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-09-041572370097, 572370098
7776a8dbc-e68e-4732-acf4-0133dca0f54c (view SPL)Cefadroxil for Oral Suspension, USPRx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-02-272658620083, 658620084
89d421f13-579c-4096-aa4e-1f931cd1d95c (view SPL)CEFADROXIL FOR ORAL SUSPENSION USP41804181prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2010-02-022000934180, 000934181

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