FDA.reportPublic FDA data

Application 019422

Type
NDA
Sponsor
XTTRIUM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXIDINECHLORHEXIDINE GLUCONATESOLUTION;TOPICAL2%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0116-0038Bactoshield CHGChlorhexidine Gluconate 2%Xttrium Laboratories, Inc.NDACurrent
0116-0113Cardinal Health Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.NDACurrent
0116-0506BD E-Z Scrubchlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-0506BD E-Z Scrubchlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-0722Scrub CareCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-0722Scrub CareCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-0722Scrub CareCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-1021DYNA-HEXChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-1021DYNA-HEXChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1021DYNA-HEXChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-1021DYNA-HEXChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1021DYNA-HEXChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-1021DYNA-HEXChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1022Dyna-Hex 2Chlorhexidine Gluconate 2%Xttrium Laboratories, Inc.NDACurrent
0116-1022Dyna-Hex 2Chlorhexidine Gluconate 2%Xttrium Laboratories, Inc.NDACurrent
0116-1022Dyna-Hex 2Chlorhexidine Gluconate 2%Xttrium Laboratories, Inc.NDACurrent
0116-1130Cardinal Health Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.NDACurrent
0116-1130Cardinal Health Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.NDACurrent
0116-1322Bactoshield CHGChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1919Aplicare Chlorhexidine Gluconate 2% SolutionChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-2800Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-2800Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-2800Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-2992Scrub CareCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-2992Scrub CareCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-4242Scrub CareCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-4242Scrub CareCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-8500Provon Antimicrobial Foam HandwashChlorhexidine Gluconate 2%Xttrium Laboratories, Inc.NDACurrent
11084-038Bactoshield CHGChlorhexidine GluconateSC Johnson Professional USA, Inc.NDACurrent
11084-814Bactoshield CHGChlorhexidine GluconateDeb USA, Inc.NDACurrent
11084-814Bactoshield CHGChlorhexidine GluconateDeb USA, Inc.NDACurrent
17271-506BD E-Z Scrubchlorhexidine gluconateBecton Dickinson and CompanyNDACurrent
17271-506BD E-Z Scrubchlorhexidine gluconateBecton Dickinson and CompanyNDACurrent
21749-106Antimicrobial Skin CleanserChlorhexidine Gluconate 2% SolutionGojo Industries, Inc.NDACurrent
21749-106Antimicrobial Skin CleanserChlorhexidine Gluconate 2% SolutionGojo Industries, Inc.NDACurrent
21749-225Purell Antimicrobial FoamChlorhexidine Gluconate 2% SolutionGOJO Industries, Inc.NDACurrent
21749-225Purell Antimicrobial FoamChlorhexidine Gluconate 2% SolutionGOJO Industries, Inc.NDACurrent
21749-225Purell Antimicrobial FoamChlorhexidine Gluconate 2% SolutionGOJO Industries, Inc.NDACurrent
21749-225Purell Antimicrobial FoamChlorhexidine Gluconate 2% SolutionGOJO Industries, Inc.NDACurrent
21749-225Purell Antimicrobial FoamChlorhexidine Gluconate 2% SolutionGOJO Industries, Inc.NDACurrent
21749-226Purell CS Foam Handwash 2% CHGChlorhexidine Gluconate 2% SolutionGOJO Industries, Inc.NDACurrent
21749-416Antimicrobial Foam HandwashChlorhexidine Gluconate 2% SolutionGOJO Industries, Inc.NDACurrent
21749-461Antiseptic Foam HandwashChlorhexidine Gluconate 2% SolutionGOJO Industries, Inc.NDACurrent
21749-850Provon Antimicrobial Foam HandwashChlorhexidine Gluconate 2%Gojo Industries, Inc.NDACurrent
21749-850Provon Antimicrobial Foam HandwashChlorhexidine Gluconate 2%Gojo Industries, Inc.NDACurrent
21749-850Provon Antimicrobial Foam HandwashChlorhexidine Gluconate 2%Gojo Industries, Inc.NDACurrent
21749-850Provon Antimicrobial Foam HandwashChlorhexidine Gluconate 2%Gojo Industries, Inc.NDACurrent
46122-659Antiseptic Skin Cleanser2% Chlorhexidine Gluconate SolutionAmerisourceBergen Drug CorporationNDACurrent
52380-1274Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare, Inc.NDACurrent
52380-1919Aplicare Chlorhexidine Gluconate 2% SolutionChlorhexidine GluconateAplicare Products, LLC.NDACurrent
52380-1919Aplicare Chlorhexidine Gluconate 2% SolutionChlorhexidine GluconateAplicare, Inc.NDACurrent
53329-994foaming hand washchlorhexidine gluconateMedline Industries, Inc.NDACurrent
53329-994foaming hand washchlorhexidine gluconateMedline Industries, lPNDACurrent
53329-994foaming hand washchlorhexidine gluconateMedline Industries, LPNDACurrent
53329-994foaming hand washchlorhexidine gluconateMedline Industries, LPNDACurrent
59779-722Scrub CareCHLORHEXIDINE GLUCONATECVS Pharmacy, Inc.NDACurrent
59779-722Scrub CareCHLORHEXIDINE GLUCONATECVS Pharmacy, Inc.NDACurrent
59779-722Scrub CareCHLORHEXIDINE GLUCONATECVS Pharmacy, Inc.NDACurrent
59779-722Scrub CareCHLORHEXIDINE GLUCONATECVS Pharmacy, Inc.NDACurrent
63517-113Cardinal Health Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 2%Cardinal HealthNDACurrent
63517-113Cardinal Health Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 2%Cardinal HealthNDACurrent
63868-280Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATEQuality ChoiceNDACurrent
63868-280Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATEQuality ChoiceNDACurrent
63868-280Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATEQuality ChoiceNDACurrent
67659-901Dyna-HexCHLORHEXIDINE GLUCONATETeam Technologies, IncNDACurrent
67659-901Dyna-HexCHLORHEXIDINE GLUCONATETeam Technologies, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84911SUPPL 2026-02-05
84910SUPPL 2026-02-05
57510SUPPL2019-02-13
57457SUPPL2019-02-06
49785SUPPL2017-09-19
33740SUPPL2014-01-14
1322SUPPL2012-12-18
1321SUPPL2009-02-27
1320SUPPL2009-02-27
40910SUPPL2007-07-09
1319SUPPL2004-12-30
17389SUPPL2003-12-23