Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/29/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf
07/29/2016 SUPPL-16 Labeling-Container/Carton Labels 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English