Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203491
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ILEVRO NEPAFENAC 0.3% SUSPENSION/DROPS;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
10/16/2012 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203491s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203491Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203491_nepafenac_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203491Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/10/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/28/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/03/2014 SUPPL-6 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203491Orig1s006ltr.pdf
12/09/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/13/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/05/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/14/2012 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203491s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203491Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/14/2012 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203491s001lbl.pdf
10/16/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203491s000lbl.pdf

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