Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125422
Company: THROMBOGENICS, INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JETREA OCRIPLASMIN 2.5MG/ML INJECTABLE; INTRAVITREAL 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
10/17/2012 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125422s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125422Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125422_jetrea_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/22/2017 SUPPL-38 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125422s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125422Orig1s038ltr.pdf
03/27/2016 SUPPL-37 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125422s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125422Orig1s037ltr.pdf
06/13/2014 SUPPL-25 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125422s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125422Orig1s025ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/22/2017 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125422s038lbl.pdf
03/27/2016 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125422s037lbl.pdf
06/13/2014 SUPPL-25 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125422s025lbl.pdf
10/17/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125422s000lbl.pdf

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