Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125460
Company: BIOMARIN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIMIZIM ELOSULFASE ALFA 5MG/5ML INJECTABLE;INJECTION Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/14/2014 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125460s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125460Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125460Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125460Orig1s000SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/14/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125460s000lbl.pdf

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