← FDA DRUG APPROVALS

FDA ANDA · ANDA204813

BROMFENAC

Sponsor: EUGIA PHARMA

APPLICATION
ANDA204813
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-18
LATEST ACTION
2022-03-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

BROMFENAC SODIUMPrescription
BROMFENAC SODIUM EQ 0.09% ACID · SOLUTION/DROPS · OPHTHALMIC

Approval history

2022-03-18UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →