Details for New Drug Application (NDA): 214965
✉ Email this page to a colleague
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 |
Pharmacology for NDA: 214965
Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 214965
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: | RX | Dosage: | EMULSION;OPHTHALMIC | Strength | 0.1% | ||||
Approval Date: | Jun 23, 2021 | TE: | 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 Up | Patent Expiration: | Jan 27, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | FOR THE TREATMENT OF VERNAL KERATOCONJUNCTIVITIS IN CHILDREN AND ADULTS |
Complete Access Available with Subscription