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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 214965


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NDA 214965 describes VERKAZIA, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the VERKAZIA profile page.

The generic ingredient in VERKAZIA 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 214965
Tradename:VERKAZIA
Applicant:Harrow Eye
Ingredient:cyclosporine
Patents:7
Suppliers and Packaging for NDA: 214965
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VERKAZIA cyclosporine EMULSION;OPHTHALMIC 214965 NDA Santen Incorporated 65086-001 65086-001-05 1 POUCH in 1 CARTON (65086-001-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE
VERKAZIA cyclosporine EMULSION;OPHTHALMIC 214965 NDA Santen Incorporated 65086-001 65086-001-12 24 POUCH in 1 CARTON (65086-001-12) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;OPHTHALMICStrength0.1%
Approval Date:Jun 23, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 23, 2028
Regulatory Exclusivity Use:FOR THE TREATMENT OF VERNAL KERATOCONJUNCTIVITIS (VKC) IN CHILDREN AND ADULTS
Regulatory Exclusivity Expiration:Jun 23, 2024
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Jan 27, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF VERNAL KERATOCONJUNCTIVITIS IN CHILDREN AND ADULTS

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