Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217469
Company: HARROW EYE

Products on NDA 217469

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VEVYE	CYCLOSPORINE	0.1%	SOLUTION;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217469

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2023	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217469s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217469Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217469Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2025	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217469s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217469Orig1s007ltr.pdf
05/28/2024	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217469s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217469Orig1s003ltr.pdf

Labels for NDA 217469

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2025	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217469s007lbl.pdf
05/28/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217469s003lbl.pdf
05/30/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217469s000lbl.pdf