Details for New Drug Application (NDA): 206911

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. 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 Action

Cyclooxygenase 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:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.075% ACID
Approval Date:	Apr 8, 2016	TE:	AB	RLD:	Yes
Patent:		Patent Expiration:	Aug 7, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF POSTOPERATIVE INFLAMMATION AND PREVENTION OF OCULAR PAIN IN PATIENTS UNDERGOING CATARACT SURGERY

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