FDA.reportPublic FDA data

Application 019125

Type
NDA
Sponsor
XTTRIUM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXIDINECHLORHEXIDINE GLUCONATESOLUTION;TOPICAL4%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0116-0039Bactoshield CHGChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0039Bactoshield CHGChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0061Cardinal HealthCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-0061Cardinal HealthCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-0115Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0115Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0115Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0137Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0137Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0137Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0161Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0161Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0161Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0162Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0162Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0162Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0200BETASEPTAntiseptic Surgical ScrubXttrium Laboratories, Inc.NDACurrent
0116-0200BETASEPTAntiseptic Surgical ScrubXttrium Laboratories, Inc.NDACurrent
0116-0228Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0228Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0228Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0237Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0237Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0237Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0401Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0401Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0407ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-0407ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-0767Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-0767Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-0767Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-1060DYNA-HEX 4Chlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1060DYNA-HEX 4Chlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1060DYNA-HEX 4Chlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1061ANTISEPTIC SKIN CLEANSERChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1061ANTISEPTIC SKIN CLEANSERChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1061ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, IncNDACurrent
0116-1061ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-1272Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1344Bactoshield CHGCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-1610Smart Sense Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-1610Smart Sense Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-2994Scrub CareChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-2994Scrub CareChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-2994Scrub CareChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-2994Scrub CareChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-3678Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-3678Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-4444Scrub CareChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-4444Scrub CareChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0363-1061Antiseptic Skin CleanserChlorhexidine Gluconate 4%Walgreen Co.NDACurrent
0363-1061Antiseptic Skin CleanserChlorhexidine Gluconate 4%Walgreen Co.NDACurrent
0404-1061Antiseptic Skin CleanserChlorhexidine Gluconate 4%Henry Schein, Inc.NDACurrent
0519-1344Bactoshield CHGCHLORHEXIDINE GLUCONATESTERIS CorporationNDACurrent
11084-039Bactoshield CHGCHLORHEXIDINE GLUCONATESC Johnson Professional USA, Inc.NDACurrent
11084-815Bactoshield CHGCHLORHEXIDINE GLUCONATEDeb USA, Inc.NDACurrent
11084-815Bactoshield CHGCHLORHEXIDINE GLUCONATEDeb USA, Inc.NDACurrent
11701-172Antiseptic SolutionChlorhexidine Gluconate 4%Coloplast CorpNDACurrent
11822-0116Antiseptic Skin CleanserChlorhexidine Gluconate 4%Rite AidNDACurrent
11822-0891Antiseptic Skin CleanserChlorhexidine Gluconate 4%Rite AidNDACurrent
11822-3678Antiseptic Skin CleanserChlorhexidine Gluconate 4%Rite Aid CorporationNDACurrent
11822-3678Antiseptic Skin CleanserChlorhexidine Gluconate 4%Rite Aid CorporationNDACurrent
36800-401Antiseptic Skin CleanserChlorhexidine Gluconate 4%Topco Associates LLCNDACurrent
36800-401Antiseptic Skin CleanserChlorhexidine Gluconate 4%Topco Associates LLCNDACurrent
37205-595ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATECardinal HealthNDACurrent
37205-595ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATECardinal HealthNDACurrent
37205-595ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATECardinal HealthNDACurrent
41250-162Antiseptic Skin CleanserChlorhexidine Gluconate 4%Meijer Distribution, Inc.NDACurrent
41250-162Antiseptic Skin CleanserChlorhexidine Gluconate 4%Meijer Distribution, Inc.NDACurrent
46122-137Antiseptic Skin CleanserChlorhexidine Gluconate 4%AmerisourceBergen Drug CorporationNDACurrent
49348-115Antiseptic Skin CleanserChlorhexidine Gluconate 4%McKessonNDACurrent
49348-115Antiseptic Skin CleanserChlorhexidine Gluconate 4%Strategic Sourcing Services, LLCNDACurrent
49348-115Antiseptic Skin CleanserChlorhexidine Gluconate 4%Strategic Sourcing Services, LLCNDACurrent
49738-161Smart Sense Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Kmart CorporationNDACurrent
49738-161Smart Sense Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Kmart CorporationNDACurrent
52380-1272Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare, Inc.NDACurrent
52380-1986Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare, Inc.NDACurrent
52380-1986Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare Products, LLC.NDACurrent
52380-1987Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare, Inc.NDACurrent
52380-1987Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare Products, LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84909SUPPL 2026-02-05
84908SUPPL 2026-02-05
72251SUPPL2022-10-05
72197SUPPL2022-09-30
49827SUPPL2017-09-21
49800SUPPL2017-09-19
33699SUPPL2014-10-30
16201SUPPL2014-10-22
1231SUPPL2012-11-13
16200SUPPL2005-05-18
20207SUPPL2003-09-11