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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 217469


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NDA 217469 describes VEVYE, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the VEVYE profile page.

The generic ingredient in VEVYE is cyclosporine. There are eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 217469
Tradename:VEVYE
Applicant:Harrow Eye
Ingredient:cyclosporine
Patents:5
Suppliers and Packaging for NDA: 217469
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VEVYE cyclosporine SOLUTION;OPHTHALMIC 217469 NDA Harrow Eye, LLC 82667-900 82667-900-00 1 BOTTLE, DROPPER in 1 CARTON (82667-900-00) / 2 mL in 1 BOTTLE, DROPPER
VEVYE cyclosporine SOLUTION;OPHTHALMIC 217469 NDA Harrow Eye, LLC 82667-900 82667-900-02 1 BOTTLE, DROPPER in 1 CARTON (82667-900-02) / 2 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;OPHTHALMICStrength0.1%
Approval Date:May 30, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:May 30, 2026
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Sep 22, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Nov 20, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

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