Orange Book product · Brand (NDA)

BROMSITE

BROMFENAC SODIUM

Brand (NDA)NDA 206911TE ABRX SUN PHARM

Apr 08, 2016

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 08, 2016
10 yr 4 mo ago
Today
Patent RE50218 expires
Listed drug product patent expiration.
Mar 05, 2029
in 2 yr 9 mo

Active ingredient

BROMFENAC SODIUM

Strength

EQ 0.075% ACID

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Application

NDA 206911

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
RE50218	Mar 05, 2029	in 2 yr 9 mo	ProductU-1834