Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022212
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DUREZOL DIFLUPREDNATE 0.05% EMULSION;OPHTHALMIC 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
06/23/2008 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022212lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022212s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022212s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022212s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2016 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022212Orig1s016ltr.pdf
04/11/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/15/2013 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022212Orig1s012ltr.pdf
03/22/2013 SUPPL-11 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022212Orig1s011ltr.pdf
11/27/2012 SUPPL-10 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022212Orig1s010ltr.pdf
06/13/2012 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022212s003ltr.pdf
03/20/2009 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022212s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/29/2016 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf
07/29/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf
05/15/2013 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s012lbl.pdf
03/22/2013 SUPPL-11 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s011lbl.pdf
11/27/2012 SUPPL-10 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s010lbl.pdf
06/13/2012 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s003lbl.pdf
06/23/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022212lbl.pdf

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