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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203491
Company: HARROW EYE

Summary Review

Products on NDA 203491

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203491

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

Labels for NDA 203491

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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