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Medicines · US (FDA)

FDA 2022

Antiinflammatory agents, non-steroids

Bromfenac Sodium

Approved 18 Mar 2022EyeSolution/drops

The FDA lists this product in 16 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: BROMFENAC SODIUM EQ 0.09% ACID

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsANDA202620-001 · Discontinued
BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsANDA203395-001 · Prescription
BROMFENAC SODIUM EQ 0.075% ACID · Solution/dropsANDA211239-001 · Prescription
BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsThis page
BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsANDA211029-001 · Prescription
BROMFENAC SODIUM EQ 0.07% ACID · Solution/dropsANDA214340-001 · Prescription
BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsANDA201211-001 · Discontinued
BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsANDA202030-001 · Discontinued
BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsANDA202903-001 · Prescription
BROMFENAC SODIUM EQ 0.07% ACID · Solution/dropsANDA210962-001 · Prescription

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsANDA202435-001 · Discontinued

BROMFENAC SODIUM EQ 0.07% ACID · Solution/dropsANDA206027-001 · Prescription

BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsANDA210560-001 · Prescription

BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsANDA201941-001 · Discontinued

BROMFENAC SODIUM EQ 0.07% ACID · Solution/dropsANDA207334-001 · Prescription

BROMFENAC SODIUM EQ 0.09% ACID · Solution/dropsANDA203368-001 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA204813.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Bromfenac Sodium
Drug class: Antiinflammatory agents, non-steroids
Route: Eye
Dosage form: Solution/drops
Applicant: Eugia Pharma
Status: Prescription
FDA approval: 18 Mar 2022
Application: ANDA204813-001
RxCUI: 47364