APPLICATION
ANDA210560
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-21
LATEST ACTION
2019-06-21
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
BROMFENAC SODIUMPrescription
BROMFENAC SODIUM EQ 0.09% ACID · SOLUTION/DROPS · OPHTHALMIC
Approval history
2019-06-21UNKNOWN · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.