FDA.reportPublic FDA data

Application 125460

Type
BLA
Sponsor
BIOMARIN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIMIZIMELOSULFASE ALFAINJECTABLE;INJECTION5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68135-100VIMIZIMelosulfase alfaBioMarin Pharmaceutical Inc.BLACurrent
68135-100VIMIZIMelosulfase alfaBioMarin Pharmaceutical Inc.BLACurrent
68135-100VIMIZIMelosulfase alfaBioMarin Pharmaceutical Inc.BLACurrent
68135-100VIMIZIMelosulfase alfaBioMarin Pharmaceutical Inc.BLACurrent
68135-100VIMIZIMelosulfase alfaBioMarin Pharmaceutical Inc.BLACurrent
68135-100VIMIZIMelosulfase alfaBioMarin Pharmaceutical Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84034SUPPL 2025-11-03
84031SUPPL 2025-10-31
61175SUPPL2019-12-06
61157SUPPL2019-12-04
44808ORIG2014-03-24
22811ORIG2014-03-24
39972ORIG2014-02-19
9760ORIG2014-02-19