FDA.reportPublic FDA data

Application 022181

Type
NDA
Sponsor
BIOMARIN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KUVANSAPROPTERIN DIHYDROCHLORIDETABLET;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-749Sapropterin DihydrochlorideSapropterin DihydrochlorideDr. Reddys Laboratories Inc.NDACurrent
43598-749Sapropterin DihydrochlorideSapropterin DihydrochlorideDr. Reddys Laboratories Inc.NDACurrent
68135-300KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-300KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-300KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-300KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-300KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent
68135-300KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79800SUPPL 2024-10-02
79560SUPPL 2024-09-09
62160SUPPL2020-03-17
62150SUPPL2020-03-17
61298SUPPL2019-12-17
61281SUPPL2019-12-16
58551SUPPL2019-05-03
58544SUPPL2019-05-03
57582SUPPL2019-02-13
57409SUPPL2019-02-04
38344SUPPL2016-06-17
29363SUPPL2016-06-15
38343SUPPL2015-11-10
29362SUPPL2014-04-24
52329SUPPL2014-03-28
52330SUPPL2014-03-13
38342SUPPL2013-12-23
38341SUPPL2013-12-23
29361SUPPL2013-12-20
7008SUPPL2013-12-20
24253ORIG2008-07-22
7007SUPPL2008-06-24
42439ORIG2008-03-24
44436ORIG2007-12-13
29360ORIG2007-12-13
17049ORIG2007-12-13
51476SUPPL1900-01-01
51475SUPPL1900-01-01