FDA.reportPublic FDA data

Application 205065

Type
NDA
Sponsor
BIOMARIN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KUVANSAPROPTERIN DIHYDROCHLORIDEPOWDER;ORAL100MG/PACKETYesYes
002KUVANSAPROPTERIN DIHYDROCHLORIDEPOWDER;ORAL500MG/PACKETYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68135-301KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-301KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-301KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-301KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-301KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-301KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-482Kuvansapropterin dihydrochlorideBioMarin Pharmaceutical Inc.NDACurrent
68135-482Kuvansapropterin dihydrochlorideBioMarin Pharmaceutical Inc.NDACurrent
68135-482Kuvansapropterin dihydrochlorideBioMarin Pharmaceutical Inc.NDACurrent
68135-482Kuvansapropterin dihydrochlorideBioMarin Pharmaceutical Inc.NDACurrent
68135-482Kuvansapropterin dihydrochlorideBioMarin Pharmaceutical Inc.NDACurrent
68135-482Kuvansapropterin dihydrochlorideBioMarin Pharmaceutical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79801SUPPL 2024-10-02
79561SUPPL 2024-09-09
62161SUPPL2020-03-17
62151SUPPL2020-03-17
61326SUPPL2019-12-17
61300SUPPL2019-12-17
58552SUPPL2019-05-03
58543SUPPL2019-05-03
45036SUPPL2016-08-09
45021SUPPL2016-08-09
19620SUPPL2016-04-08
24486ORIG2014-03-06
22973ORIG2014-03-06
19619ORIG2013-12-23
32625ORIG2013-12-20