FDA.reportPublic FDA data

Application 021669

Type
NDA
Sponsor
SAGE PRODS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATECLOTH;TOPICAL2%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53462-007Skin antisepsis, oral cleansing, nasal antisepsisCHLORHEXIDINE GLUCONATESage Products, Inc.NDACurrent
53462-007Skin antisepsis, oral cleansing, nasal antisepsisCHLORHEXIDINE GLUCONATESage Products LLCNDACurrent
53462-008Skin antisepsis, oral cleansing, nasal antisepsisCHLORHEXIDINE GLUCONATESage Products, Inc.NDACurrent
53462-009Skin Antisepsis, Oral Cleansing and Nasal Antisepsis SystemCHLORHEXIDINE GLUCONATESage Products, LLCNDACurrent
53462-009Skin Antisepsis, Oral Cleansing and Nasal Antisepsis SystemCHLORHEXIDINE GLUCONATESage Products, LLCNDACurrent
53462-110Skin Antisepsis, Oral Cleansing and Nasal Antisepsis SystemCHLORHEXIDINE GLUCONATESage Products, LLCNDACurrent
53462-705CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATESage Products LLCNDACurrent
53462-705CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATESage Products LLCNDACurrent
53462-705CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATESage Products LLCNDACurrent
53462-705Chlorhexidine GluconateChlorhexidine GluconateSage Products LLCNDACurrent
86994-001LARA MED Antibacterial Wet WipesCHLORHEXIDINE GLUCONATELARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETINDACurrent
86994-001LARA MED Antibacterial Wet WipesCHLORHEXIDINE GLUCONATELARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETINDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49705SUPPL2017-09-08
49699SUPPL2017-09-08
15951SUPPL2014-07-31
5952SUPPL2014-06-25
5951SUPPL2012-05-23
21773SUPPL2011-01-07
21772ORIG2007-01-22
28340SUPPL2006-08-21
15950SUPPL2006-08-18
28339SUPPL2006-01-20
37428ORIG2005-04-28
5950ORIG2005-04-28