Last Updated: September 27, 2026

Details for New Drug Application (NDA): 206911


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NDA 206911 describes BROMSITE, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the BROMSITE profile page.

The generic ingredient in BROMSITE is bromfenac sodium. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for 206911
Tradename:BROMSITE
Applicant:Sun Pharm
Ingredient:bromfenac sodium
Patents:1
Pharmacology for NDA: 206911
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 206911
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROMSITE bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 206911 NDA Sun Pharmaceutical Industries, Inc. 49708-754 49708-754-41 1 POUCH in 1 CARTON (49708-754-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER
BROMSITE bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 206911 NDA AUTHORIZED GENERIC Sun Pharmaceutical Industries, Inc. 49708-755 49708-755-41 1 POUCH in 1 CARTON (49708-755-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.075% ACID
Approval Date:Apr 8, 2016TE:ABRLD:Yes
Patent:⤷  Start TrialPatent Expiration:Mar 5, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF POSTOPERATIVE INFLAMMATION AND PREVENTION OF OCULAR PAIN IN PATIENTS UNDERGOING CATARACT SURGERY

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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