FLAREX (FLUOROMETHOLONE ACETATE)
Summary
FDA approved FLAREX (FLUOROMETHOLONE ACETATE) by HARROW EYE. NDA (New Drug) approval (Labeling) on 2025-09-23. SUSPENSION/DROPS, OPHTHALMIC.
Details
Source
Drug Approval
External ID
NDA019079-41
Action Date
2025-09-23
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
FLAREX (generic: FLUOROMETHOLONE ACETATE), SUSPENSION/DROPS, OPHTHALMIC. Application: NDA019079
Company
Context & Analysis
HARROW EYE has 7 FDA actions in our database.
Frequently Asked Questions
How often does HARROW EYE have FDA actions?
HARROW EYE has 7 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA019079-41" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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