General MedicationsOPHTHALMICStandard
IOPIDINE
APRACLONIDINE HYDROCHLORIDE
Standard Dose
EQ 1% BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview IOPIDINE is listed in Drugs@FDA under application 019779 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient APRACLONIDINE HYDROCHLORIDE Form and strength SOLUTION/DROPS;OPHTHALMIC - EQ 1% BASE Sponsor HARROW EYE Submission history Latest submission status date: 2026-03-18 00:00:00.
Structured Monograph
Clinical summary
Approval overview IOPIDINE is listed in Drugs@FDA under application 019779 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient APRACLONIDINE HYDROCHLORIDE Form and strength SOLUTION/DROPS;OPHTHALMIC - EQ 1% BASE Sponsor HARROW EYE Submission history Latest submission status date: 2026-03-18 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.