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Active ingredient

Bromfenac

18 finished FDA listings contain Bromfenac as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
BROMFENAC, BROMFENAC SODIUM
Dosage forms
Solution, Solution/ Drops
Routes
Ophthalmic
Manufacturers / labelers
13
Strengths listed
.7 mg/ml · .75 mg/ml · .76 mg/ml · .805 mg/ml · .9 mg/ml · 1.035 mg/ml
Brand names in FDA listings
Bromfenac 0.075%, Bromfenac Ophthalmic Solution, Bromfenac Ophthalmic Solution, 0.07%, Bromsite 0.075%, Prolensa

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 19737

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 203168BAUSCH AND LOMB2013-04-053
ANDA 203395SENTISS2014-01-221
NDA 206911SUN PHARM2016-04-082
ANDA 210560ALEMBIC2019-06-212
ANDA 211029GLAND2020-03-172
ANDA 204813EUGIA PHARMA2022-03-181
ANDA 202903LUPIN2023-08-151
ANDA 206027LUPIN2023-11-221
ANDA 211239LUPIN2024-02-021
ANDA 207334APOTEX2024-07-081
ANDA 214340ALEMBIC2024-07-082
ANDA 210962AMNEAL2024-07-291

Official labeling on DailyMed

Showing the 12 most recent of 18 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.