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.
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: | 11,612,658 | Patent Expiration: | Jan 27, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE TREATMENT OF VERNAL KERATOCONJUNCTIVITIS IN CHILDREN AND ADULTS | ||||||||
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