General MedicationsOPHTHALMICStandard
AKTEN
LIDOCAINE HYDROCHLORIDE
Standard Dose
3.5%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview AKTEN is listed in Drugs@FDA under application 022221 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LIDOCAINE HYDROCHLORIDE Form and strength GEL;OPHTHALMIC - 3.5% Sponsor THEA PHARMA Submission history Latest submission status date: 2025-11-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview AKTEN is listed in Drugs@FDA under application 022221 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LIDOCAINE HYDROCHLORIDE Form and strength GEL;OPHTHALMIC - 3.5% Sponsor THEA PHARMA Submission history Latest submission status date: 2025-11-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.