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Zerviate

ZERVIATE™ (cetirizine ophthalmic solution) 0.24%, for topical ophthalmic use These highlights do not include all the information needed to use ZERVIATE safely and effectively. See full prescribing information for ZERVIATE. Initial U.S. Approval: 1995

Approved
Approval ID

3e6fecc1-df71-4c01-a654-f55635617a7f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 9, 2023

Manufacturers
FDA

Eyevance Pharmaceuticals

DUNS: 080876046

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cetirizine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71776-024
Application NumberNDA208694
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cetirizine
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 9, 2023
FDA Product Classification

INGREDIENTS (11)

BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETIRIZINEActive
Quantity: 2.4 mg in 1 mL
Code: YO7261ME24
Classification: ACTIB

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Zerviate - FDA Drug Approval Details