← FDA DRUG APPROVALS

FDA NDA · NDA022221

AKTEN

lidocaine hydrochloride anhydrous

Sponsor: THEA PHARMA

APPLICATION
NDA022221
TYPE
NDA
ORIGINAL APPROVAL
2008-10-07
LATEST ACTION
2025-11-21
ROUTE
OPHTHALMIC
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

AKTEN · ReferencePrescription
LIDOCAINE HYDROCHLORIDE 3.5% · GEL · OPHTHALMIC

Approval history

2025-11-21Labeling · Supplement 11 · standard — Letter ↗AP
2022-02-28Labeling · Supplement 8 · standard — Letter ↗AP
2014-03-11Labeling · Supplement 5 · standard — Letter ↗AP
2012-12-07Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2008-10-07Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →