Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020474
Company: HARROW EYE

Products on NDA 20474

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VEXOL	RIMEXOLONE	1%	SUSPENSION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Labels for NDA 020474

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2012	SUPPL-21	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020474s021lbl.pdf
10/18/2007	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020474s019lbl.pdf
04/17/2003	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20474slr016_vexol_lbl.pdf