Documents
Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 5MG/5ML | 0 | VIMIZIM | ELOSULFASE ALFA |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-02-14 | PRIORITY |
LABELING; Labeling | SUPPL | 17 | AP | 2019-12-04 | STANDARD |
Submissions Property Types
CDER Filings
BIOMARIN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 125460
[companyName] => BIOMARIN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"VIMIZIM","activeIngredients":"ELOSULFASE ALFA","strength":"5MG\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125460s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125460s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"02\/14\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125460s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125460Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125460Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125460Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-17","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125460s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125460Orig1s017ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-12-04
)
)