Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125499
Company: BIOGEN IDEC INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLEGRIDY PEGINTERFERON BETA-1A 125MICROGRAMS/0.5ML 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
08/15/2014 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125499s000ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2019 SUPPL-19 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125499s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125499Orig1s019ltr.pdf
07/14/2016 SUPPL-11 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125499Orig1s011ltr.pdf
12/22/2015 SUPPL-9 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125499s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125499s009ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/10/2019 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125499s019lbl.pdf
07/10/2019 SUPPL-19 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125499s019lbl.pdf
07/14/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf
07/14/2016 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf
12/22/2015 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125499s009lbl.pdf
08/15/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499lbl.pdf

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