FDA.reportPublic FDA data

Application 203195

Type
NDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUPRAXCEFIXIMECAPSULE;ORAL400MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27437-208SUPRAXcefiximeLupin Pharmaceuticals, Inc.NDACurrent
27437-208SUPRAXcefiximeLupin Pharmaceuticals, Inc.NDACurrent
43063-537SUPRAXcefiximePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-537SUPRAXcefiximePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-537SUPRAXcefiximePD-Rx Pharmaceuticals, Inc.NDACurrent
68180-423CEFIXIMECEFIXIMELupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-423CEFIXIMECEFIXIMELupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70518-1020SUPRAXcefiximeREMEDYREPACK INC.NDACurrent
70518-2006SUPRAXcefiximeREMEDYREPACK INC.NDACurrent
70518-3221CEFIXIMECEFIXIMEREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-3221CEFIXIMECEFIXIMEREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-3221CEFIXIMECEFIXIMEREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70934-079SUPRAXcefiximeDenton Pharma, Inc.NDACurrent
70934-079SUPRAXcefiximeDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82413SUPPL 2025-06-02
82315SUPPL 2025-05-27
73444SUPPL 2023-02-09
53566SUPPL2018-04-01
53526SUPPL2018-03-29
47597SUPPL2017-03-20
47578SUPPL2017-03-17
40273SUPPL2016-01-12
10182SUPPL2016-01-11
19445SUPPL2013-04-01
44879ORIG2012-11-16
43424ORIG2012-11-16
10181ORIG2012-06-07
40272ORIG2012-06-05