Cefixime Oral Tablet

Brand(s)
Suprax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lupin Limited (2014-09-11)
Oldest Current Product
2008-04-01
License(s)
ANDA
RxNORM
ORAL TABLET\CEFIXIME
FDAOB
ORAL\TABLET\CEFIXIME
SPL Active
ORAL\TABLET\CEFIXIME
SPL Moiety
ORAL\TABLET\CEFIXIME ANHYDROUS

product(s) by strength(s)

cefixime 400 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1274370201SupraxANDALupin Pharma2008-04-01CEFIXIMEORALTABLETANDA065130d0fd45bd-7d52-4fa6-a5f7-f46d5651ffa2
2572970201SupraxANDALupin Limited2008-04-01CEFIXIMEORALTABLETANDA0651305007152e-a679-4e85-ac3f-c46087812774

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545692861SupraxANDAA-S Medication Solutions Llc2008-04-01CEFIXIMEORALTABLET274370201ANDA065130e5b73566-6be1-4aa5-8c16-3b32aa0bc3f0
2552890954SupraxANDAPd-Rx Pharmaceuticals, Inc.2008-04-01CEFIXIMEORALTABLET274370201ANDA065130567c8c7a-72ca-47cc-93a8-b59e55d2aa56
3636294639SupraxANDABryant Ranch Prepack2008-04-01CEFIXIMEORALTABLET274370201ANDA065130da3a1d05-da4a-4399-acb4-f763e987c901

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065130SUPRAXLUPIN PHARMACEUTICALS INC2004-02-12ANDA065130_001
2NDA050621SUPRAXTrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID CO1989-04-28NDA050621_001, NDA050621_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA065130_001RXCEFIXIME (400MG)ORALTABLETTrue2004-02-12SUPRAX
2NDA050621_001discontinuedCEFIXIME (200MG)ORALTABLETFalse1989-04-28SUPRAX
3NDA050621_002discontinuedCEFIXIME (400MG)ORALTABLETFalse1989-04-28SUPRAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15007152e-a679-4e85-ac3f-c46087812774 (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 mLFor oral administrationInitial U.S. Approval:1986To 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 Limitedmanufacture2014-09-111572970201
2567c8c7a-72ca-47cc-93a8-b59e55d2aa56 (view SPL)SUPRAXCEFIXIME TABLETS USP, 400 mgCEFIXIME FOR ORAL SUSPENSION USP, 100 mg/5 mLCEFIXIME FOR ORAL SUSPENSION USP, 200 mg/5 mLprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-11-281552890954
3d0fd45bd-7d52-4fa6-a5f7-f46d5651ffa2 (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 mLFor oral administrationInitial U.S. Approval:1986To 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 Pharmamanufacture2014-09-035274370201
4da3a1d05-da4a-4399-acb4-f763e987c901 (view SPL)SUPRAXCEFIXIME TABLETS USP, 400 mgCEFIXIME FOR ORAL SUSPENSION USP, 100 mg/5 mLCEFIXIME FOR ORAL SUSPENSION USP, 200 mg/5 mLprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-211000636294639
5e5b73566-6be1-4aa5-8c16-3b32aa0bc3f0 (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 mLFor oral administrationInitial U.S. Approval:1986To 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 PrescriptionA-S Medication Solutions Llcrepack2013-06-201545692861

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