Orange Book product · Brand (NDA)

AKTEN

LIDOCAINE HYDROCHLORIDE

Brand (NDA)NDA 022221RX THEA PHARMA

Oct 07, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 07, 2008
17 yr 11 mo ago
Today
Patent 8759401 expires
Listed drug product patent expiration.
Jul 24, 2026
in 1 mo

Active ingredient

LIDOCAINE HYDROCHLORIDE

Strength

3.5%

Dosage form

GEL

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 022221

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8759401	Jul 24, 2026	in 1 mo	ProductU-1523