Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125513
Company: ALEXION PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STRENSIQ ASFOTASE ALFA 18MG/0.45ML SOLUTION;INJECTION Prescription None No No
STRENSIQ ASFOTASE ALFA 28MG/0.7ML SOLUTION;INJECTION Prescription None No No
STRENSIQ ASFOTASE ALFA 40MG/ML SOLUTION;INJECTION Prescription None No No
STRENSIQ ASFOTASE ALFA 80MG/0.8ML SOLUTION;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
10/23/2015 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125513s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125513Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125513Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125513Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/26/2018 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125513s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125513Orig1s003ltr.pdf
10/18/2016 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125513s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125513Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/26/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125513s003lbl.pdf
10/18/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125513s002lbl.pdf
10/23/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125513s000lbl.pdf

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