Details for New Drug Application (NDA): 208694
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NDA 208694 describes ZERVIATE, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ZERVIATE profile page.
The generic ingredient in ZERVIATE is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
The generic ingredient in ZERVIATE is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 208694
| Tradename: | ZERVIATE |
| Applicant: | Harrow Eye |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 4 |
Pharmacology for NDA: 208694
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 208694
Suppliers and Packaging for NDA: 208694
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZERVIATE | cetirizine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 208694 | NDA | Harrow Eye, LLC | 82667-015 | 82667-015-24 | 1 POUCH in 1 CARTON (82667-015-24) / 30 VIAL, SINGLE-USE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.24% BASE | ||||
| Approval Date: | May 30, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 8,829,005*PED | Patent Expiration: | Sep 15, 2030 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 9,254,286*PED | Patent Expiration: | Jan 9, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 9,750,684 | Patent Expiration: | Mar 15, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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