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BROMSITE

NDA · New Drug Application · Sponsor: SUN PHARM · Approved 2016-04-08

Drug application

FDA Application #

NDA206911

Application type

New Drug Application

Brand name

BROMSITE

Generic name

BROMFENAC

Active ingredients

BROMFENAC SODIUM

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

SUN PHARM

Manufacturer

Sun Pharmaceutical Industries, Inc.

First approval

2016-04-08

Source

Authoritative

Drugs@FDA application overview

Machine

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