FDA.reportPublic FDA data

Application 077789

Type
ANDA
Sponsor
XTTRIUM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATESOLUTION;DENTAL0.12%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0116-0003Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.ANDACurrent
0116-0003Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.ANDACurrent
0116-0101Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-0101Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-0175Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-0175Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-0175Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-0244Denti-Care Denti-RinseChlorhexidine GluconanteXttrium Laboratories, Inc.ANDACurrent
0116-0244Denti-Care Denti-RinseChlorhexidine GluconanteXttrium Laboratories, Inc.ANDACurrent
0116-0301Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-0301Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-0800NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.ANDACurrent
0116-0800NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.ANDACurrent
0116-0800NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.ANDACurrent
0116-2001Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-2001Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-2001Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-2001Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, IncANDACurrent
0116-4075Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral RinseXttrium Laboratories, Inc.ANDACurrent
0116-4075Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral RinseXttrium Laboratories, Inc.ANDACurrent
0116-4075Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral RinseXttrium Laboratories, Inc.ANDACurrent
0116-6000Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.ANDACurrent
0116-6720Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral RinseXttrium Laboratories, Inc.ANDACurrent
0116-6720Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral RinseXttrium Laboratories, Inc.ANDACurrent
0116-6720Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral RinseXttrium Laboratories, Inc.ANDACurrent
0126-0035Periogard (Chlorhexidine Gluconate)Chlorhexidine GluconateColgate Oral Pharmaceuticals, Inc.ANDACurrent
0126-0035Periogard (Chlorhexidine Gluconate)Chlorhexidine GluconateColgate Oral Pharmaceuticals, Inc.ANDACurrent
0126-0035Periogard (Chlorhexidine Gluconate)Chlorhexidine GluconateColgate Oral Pharmaceuticals, Inc.ANDACurrent
0404-4075Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral RinseHenry Schein, Inc.ANDACurrent
0404-4075Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral RinseHenry Schein, Inc.ANDACurrent
0404-4075Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral RinseHenry Schein, Inc.ANDACurrent
0404-6720Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral RinseHenry Schein, Inc.ANDACurrent
0904-7035Major Oral Rinse0.12% Chlorhexidine GluconateMajor PharmaceuticalsANDACurrent
0904-7035Major Oral Rinse0.12% Chlorhexidine GluconateMajor PharmaceuticalsANDACurrent
17856-2001Chlorhexidine GluconateChlorhexidine GluconateAtlantic Biologicals Corps.ANDACurrent
17856-2002Chlorhexidine GluconateChlorhexidine GluconateAtlantic Biologicals CorpsANDACurrent
17856-2002Chlorhexidine GluconateChlorhexidine GluconateAtlantic Biologicals CorpsANDACurrent
21695-025Chlorhexidine GluconateChlorhexidine GluconateRebel Distributors CorpANDACurrent
24451-001Chlorhexidine GluconateChlorhexidine GluconateLLC Federal SolutionsANDACurrent
48433-214Chlorhexidine gluconateChlorhexidine gluconateSafecor Health, LLCANDACurrent
48433-214Chlorhexidine gluconateChlorhexidine gluconateSafecor Health, LLCANDACurrent
50090-0722Chlorhexidine GluconateChlorhexidine GluconateA-S Medication SolutionsANDACurrent
50090-0722Chlorhexidine GluconateChlorhexidine GluconateA-S Medication SolutionsANDACurrent
50090-0722Chlorhexidine GluconateChlorhexidine GluconateA-S Medication SolutionsANDACurrent
50090-0722Chlorhexidine GluconateChlorhexidine GluconateA-S Medication SolutionsANDACurrent
50227-0101Chlorhexidine GluconateChlorhexidine GluconatePatterson Dental Supply Inc.ANDACurrent
50227-0101Chlorhexidine GluconateChlorhexidine GluconatePatterson Dental Supply Inc.ANDACurrent
50227-0101Chlorhexidine GluconateChlorhexidine GluconatePatterson Dental Supply Inc.ANDACurrent
50227-0101Chlorhexidine GluconateChlorhexidine GluconatePatterson Dental Supply Inc.ANDACurrent
50227-0101Chlorhexidine GluconateChlorhexidine GluconatePatterson Dental Supply Inc.ANDACurrent
50436-2002Chlorhexidine GluconateChlorhexidine GluconateUnit Dose ServicesANDACurrent
53002-5110Chlorhexidine GluconateChlorhexidine GluconateRPK Pharmaceuticals, Inc.ANDACurrent
53002-5110Chlorhexidine GluconateChlorhexidine GluconateRPK Pharmaceuticals, Inc.ANDACurrent
53149-4840Chlorhexidine GluconateChlorhexidine GluconateAll Pharma, LLCANDACurrent
53149-4840Chlorhexidine GluconateChlorhexidine GluconateAll Pharma, LLCANDACurrent
53329-301Chlorhexidine GluconateChlorhexidine GluconateMedline Industries, Inc.ANDACurrent
53329-301Chlorhexidine GluconateChlorhexidine GluconateMedline Industries, Inc.ANDACurrent
53329-301Chlorhexidine GluconateChlorhexidine GluconateMedline Industries, LPANDACurrent
53329-301Chlorhexidine GluconateChlorhexidine GluconateMedline Industries, LPANDACurrent
53462-003Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESage Products LLCANDACurrent
53462-003Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESage Products LLCANDACurrent
55154-3573Major Oral Rinse0.12% Chlorhexidine GluconateCardinal HealthANDACurrent
55154-3574Major Oral Rinse0.12% Chlorhexidine GluconateCardinal HealthANDACurrent
59883-175Chlorhexidine GluconateChlorhexidine GluconateDen-mat Holdings, LlcANDACurrent
59883-175Chlorhexidine GluconateChlorhexidine GluconateDen-mat Holdings, LlcANDACurrent
60687-616Chlorhexidine GluconateChlorhexidine GluconateAmerican Health PackagingANDACurrent
63187-685Chlorhexidine GluconateChlorhexidine GluconateProficient Rx LPANDACurrent
63187-685Chlorhexidine GluconateChlorhexidine GluconateProficient Rx LPANDACurrent
63187-685Chlorhexidine GluconateChlorhexidine GluconateProficient Rx LPANDACurrent
63187-685Chlorhexidine GluconateChlorhexidine GluconateProficient Rx LPANDACurrent
63739-052Sky Oral RinseChlorhexidine GluconateMcKessonANDACurrent
63739-052Sky Oral RinseChlorhexidine GluconateMcKessonANDACurrent
63739-052Sky Oral RinseChlorhexidine GluconateMcKessonANDACurrent
64778-0244Chlorhexidine GluconanteChlorhexidine GluconanteAMD Medicom Inc.ANDACurrent
64778-0244Chlorhexidine GluconanteChlorhexidine GluconanteAMD Medicom Inc.ANDACurrent
64778-0244Chlorhexidine GluconanteChlorhexidine GluconanteAMD Medicom Inc.ANDACurrent
65222-800NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEDentsply LLC. Professional Division Trading as "DENTSPLY Professional"ANDACurrent
65222-800NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEDentsply LLC. Professional Division Trading as "DENTSPLY Professional"ANDACurrent
66467-2560Chlorhexidine GluconateChlorhexidine GluconateDarby Dental Supply, LLCANDACurrent
66467-2560Chlorhexidine GluconateChlorhexidine GluconateDarby Dental Supply, LLCANDACurrent