Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125117
Company: BIOMARIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAGLAZYME GALSULFASE 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
05/31/2005 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125117_0000_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125117_0000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/125117s000_NaglazyneTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/26/2013 SUPPL-111 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125117s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125117Orig1s111ltr.pdf
04/28/2011 SUPPL-90 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf
04/28/2011 SUPPL-88 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf
04/28/2011 SUPPL-86 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/26/2013 SUPPL-111 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125117s111lbl.pdf
04/28/2011 SUPPL-90 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf
04/28/2011 SUPPL-88 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf
04/28/2011 SUPPL-86 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf
05/31/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125117_0000_lbl.pdf

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