Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021862
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEVANAC NEPAFENAC 0.1% 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
08/19/2005 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021862lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021862ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021862s000_NevanacTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2017 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021862s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021862Orig1s013ltr.pdf
03/07/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/27/2011 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021862s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021862s008ltr.pdf
05/08/2008 SUPPL-2 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021862s002lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/15/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021862s013lbl.pdf
06/27/2011 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021862s008lbl.pdf
06/27/2011 SUPPL-8 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021862s008lbl.pdf
05/08/2008 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021862s002lbl.pdf
08/19/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021862lbl.pdf

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