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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 020474

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020474

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1994	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020474s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020474s021ltr.pdf
10/18/2007	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020474s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020474s019ltr.pdf
04/17/2003	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20474slr016_vexol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20474slr016ltr.pdf
03/16/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
09/18/2000	SUPPL-14	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/18/2000	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/17/1999	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
04/07/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/05/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/11/1999	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
01/22/1999	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/11/1998	SUPPL-7	Labeling		Label is not available on this site.
11/09/1999	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/26/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/01/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/20/1998	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/14/1996	SUPPL-2	Labeling		Label is not available on this site.
05/10/1995	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

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

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