Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022315
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OZURDEX DEXAMETHASONE 0.7MG IMPLANT;INTRAVITREAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/17/2009 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022315lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022315s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022315_ozurdex_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022315s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/15/2018 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022315s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022315Orig1s012ltr.pdf
02/05/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/26/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s010ltr.pdf
06/28/2014 SUPPL-9 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022315Orig1s009.pdf
02/07/2014 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s008ltr.pdf
09/07/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022315Orig1s007ltr.pdf
02/24/2012 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022315s005ltr.pdf
09/24/2010 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022315s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022315s003ltr.pdf
08/31/2010 SUPPL-2 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022315s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/15/2018 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022315s012lbl.pdf
09/26/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s010lbl.pdf
06/28/2014 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s009lbl.pdf
02/07/2014 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s008lbl.pdf
09/07/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s007lbl.pdf
02/24/2012 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s005lbl.pdf
09/24/2010 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022315s003lbl.pdf
06/17/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022315lbl.pdf

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