MedPath
FDA Product

AKTEN

Product approved by U.S. Food and Drug Administration (US)

Basic Information

AKTEN

82584-792

Regulatory Information

82584-792

NDA022221

C73594

September 5, 2023

USA

These highlights do not include all the information needed to use AKTEN safely and effectively. See full prescribing information for Akten . AKTEN (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use. Initial U.S. Approval: 1972

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

Thea Pharma Inc.

117787029

Active Ingredients

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Quantity: 35 mg in 1 mL

Code: EC2CNF7XFP

Class Code: ACTIB

Active Moieties

LIDOCAINE

Code: 98PI200987

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