Bromfenac Sodium

ANDA 201211, held by Coastal Pharms. Bromfenac Sodium.

As of Nov 15, 2026, ANDA 201211 (Bromfenac Sodium), held by Coastal Pharms, was first approved by FDA on May 11, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: May 11, 2011
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 11, 2011	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bromfenac SodiumEQ 0.09% ACID · solution/drops;ophthalmic	Bromfenac Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jan 9, 2013	Supplement 2Labeling · Standard review	Approved	None posted
May 11, 2011	Original application	Approved	Letter

Identifiers

Application: ANDA 201211
Drugs@FDA: Overview at FDA
Company: Coastal Pharms

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters