Cefixime Oral Suspension

Brand(s)
Suprax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Aurobindo Pharma Limited (2015-04-18)
Oldest Current Product
2004-03-01
License(s)
ANDA
RxNORM
ORAL SUSPENSION\CEFIXIME
FDAOB
ORAL\FOR SUSPENSION\CEFIXIME
SPL Active
ORAL\POWDER, FOR SUSPENSION\CEFIXIME
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\CEFIXIME ANHYDROUS

product(s) by strength(s)

cefixime 20 mg/ml oral suspension

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1658620751ANDAAurobindo Pharma Limited2015-04-14CEFIXIMEORALPOWDER, FOR SUSPENSIONANDA204835068e6edd-a5fe-40d8-8dcf-ac82b78dced4
2681800202SupraxANDALupin Pharmaceuticals, Inc.2004-03-01CEFIXIMEORALPOWDER, FOR SUSPENSIONANDA0651297e2462b2-bfed-4da4-8c47-46838d6153f8
3681800405ANDALupin Pharmaceuticals, Inc.2015-04-20CEFIXIMEORALPOWDER, FOR SUSPENSIONANDA0651296d68dbd9-7d75-4ff1-91db-79ff8ae879ec

cefixime 40 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1658620752ANDAAurobindo Pharma Limited2015-04-14CEFIXIMEORALPOWDER, FOR SUSPENSIONANDA204835068e6edd-a5fe-40d8-8dcf-ac82b78dced4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065129SUPRAXLUPIN PHARMACEUTICALS INC2004-02-23ANDA065129_001
2ANDA065355SUPRAXLUPIN PHARMACEUTICALS INC2007-04-10ANDA065355_001
3ANDA204835CEFIXIMEAUROBINDO PHARMA LTD2015-04-14ANDA204835_001, ANDA204835_002
4NDA050622SUPRAXTrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID CO1989-04-28NDA050622_001
5NDA202091SUPRAXLUPIN LTD2013-02-20NDA202091_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065129_001RXCEFIXIME (100MG/5ML)ORALFOR SUSPENSIONFalseAB2004-02-23SUPRAX
2ANDA065355_001RXCEFIXIME (200MG/5ML)ORALFOR SUSPENSIONFalseAB2007-04-10SUPRAX
3ANDA204835_001RXCEFIXIME (100MG/5ML)ORALFOR SUSPENSIONFalseAB2015-04-14CEFIXIME
4ANDA204835_002RXCEFIXIME (200MG/5ML)ORALFOR SUSPENSIONFalseAB2015-04-14CEFIXIME
5NDA050622_001discontinuedCEFIXIME (100MG/5ML)ORALFOR SUSPENSIONFalse1989-04-28SUPRAX
6NDA202091_001RXCEFIXIME (500MG/5ML)ORALFOR SUSPENSIONTrue2013-02-20SUPRAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1068e6edd-a5fe-40d8-8dcf-ac82b78dced4 (view SPL)These highlights do not include all the information needed to use cefixime for oral suspension safely and effectively. See full prescribing information for cefixime for oral suspension USP. CEFIXIME for Oral Suspension USP, for Oral Use Initial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-04-181658620751, 658620752
26d68dbd9-7d75-4ff1-91db-79ff8ae879ec (view SPL)These highlights do not include all the information needed to use Cefixime for Oral Suspension USP safely and effectively. See full prescribing information for Cefixime for Oral Suspension USP. CEFIXIME for Oral Suspension USP, 100 mg/5 mLCEFIXIME for Oral Suspension USP, 200 mg/5 mL For oral administration Initial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.manufacture, pack2015-04-181681800405
37e2462b2-bfed-4da4-8c47-46838d6153f8 (view SPL)These highlights do not include all the information needed to use SUPRAX safely and effectively. See full prescribing information for SUPRAX.Suprax (cefixime) Tablets USP, 400 mgSuprax (cefixime) Capsules, 400 mgSuprax (cefixime) Chewable Tablets, 100 mg, 150 mg and 200 mgSuprax (cefixime) for Oral Suspension USP, 100 mg/5 mLSuprax (cefixime) for Oral Suspension USP, 200 mg/5 mLSuprax (cefixime) for Oral Suspension USP, 500 mg/5 mL For oral administration Initial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Suprax and other antibacterial drugs, Suprax should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.manufacture2014-09-083681800202

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