Details for New Drug Application (NDA): 216227
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NDA 216227 describes IHEEZO, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the IHEEZO profile page.
The generic ingredient in IHEEZO is chloroprocaine hydrochloride. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.
The generic ingredient in IHEEZO is chloroprocaine hydrochloride. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.
Summary for 216227
| Tradename: | IHEEZO |
| Applicant: | Harrow Eye |
| Ingredient: | chloroprocaine hydrochloride |
| Patents: | 1 |
Pharmacology for NDA: 216227
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 216227
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IHEEZO | chloroprocaine hydrochloride | GEL;OPHTHALMIC | 216227 | NDA | Harrow Eye, LLC | 82667-300 | 82667-300-00 | 1 POUCH in 1 CARTON (82667-300-00) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL |
| IHEEZO | chloroprocaine hydrochloride | GEL;OPHTHALMIC | 216227 | NDA | Harrow Eye, LLC | 82667-300 | 82667-300-01 | 1 POUCH in 1 CARTON (82667-300-01) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;OPHTHALMIC | Strength | 3% | ||||
| Approval Date: | Sep 27, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 27, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 15, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF INDUCING OCULAR ANESTHESIA | ||||||||
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