FDA.reportPublic FDA data

Application 020774

Type
NDA
Sponsor
DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERIOCHIPCHLORHEXIDINE GLUCONATETABLET;DENTAL2.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52096-001PerioChipChlorhexidine GluconateAdrian Pharmaceuticals, LLCNDACurrent
64239-101PerioChipChlorhexidine GluconateDexcel Pharma Technologies Ltd.NDACurrent
64239-101PerioChipChlorhexidine GluconateDexcel Pharma Technologies Ltd.NDACurrent
64239-101PerioChipChlorhexidine GluconateDexcel Pharma Technologies Ltd.NDACurrent
64239-101PerioChipChlorhexidine GluconateDexcel Pharma Technologies Ltd.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
3317SUPPL2012-11-09
13397SUPPL2012-11-08
35317SUPPL2012-01-23
25771SUPPL2012-01-17
13396SUPPL2011-07-07
3316SUPPL2011-06-14
35316SUPPL2004-04-05
25770SUPPL2004-03-03
35315SUPPL2002-12-15
25769SUPPL2002-12-15
20931ORIG1998-05-15
13395ORIG1998-05-15
3315ORIG1998-05-15