FDA.reportPublic FDA data

Application 019931

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KLARONSULFACETAMIDE SODIUMLOTION;TOPICAL10%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5198Klaronsulfacetamide sodiumBausch Health Americas, Inc.NDACurrent
0187-5198Klaronsulfacetamide sodiumBausch Health US, LLCNDACurrent
0187-5198Klaronsulfacetamide sodiumValeant Pharmaceuticals North America LLCNDACurrent
68682-010Sodium sulfacetamideSodium sulfacetamideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-010Sodium sulfacetamideSodium sulfacetamideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-010Sodium sulfacetamideSodium sulfacetamideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19847SUPPL2010-07-08
34103SUPPL2010-07-06
11853SUPPL2004-06-07
1816SUPPL2004-06-07
41097ORIG1997-11-17