FDA.reportPublic FDA data

Application 019028

Type
NDA
Sponsor
3M

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERIDEXCHLORHEXIDINE GLUCONATESOLUTION;DENTAL0.12%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0116-0620Peridexchlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-0620Peridexchlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-0620Peridexchlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-0620Peridexchlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0904-7035Major Oral Rinse0.12% Chlorhexidine GluconateMajor PharmaceuticalsNDACurrent
48878-0620Peridexchlorhexidine gluconate3M ESPE Dental ProductsNDACurrent
48878-0620Peridexchlorhexidine gluconate3M ESPE Dental ProductsNDACurrent
48878-0620Peridexchlorhexidine gluconate3M ESPE Dental ProductsNDACurrent
48878-0620Peridexchlorhexidine gluconate3M ESPE Dental ProductsNDACurrent
63739-052Sky Oral RinseChlorhexidine GluconateMcKessonNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11418SUPPL2013-01-22
1208SUPPL2013-01-22
11419SUPPL2013-01-14
16177SUPPL2010-10-04