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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 211029

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NDA 211029 describes BROMFENAC SODIUM, which is a drug marketed by Alembic, Amneal, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland, Lupin Ltd, Rising, and Sentiss, and is included in sixteen NDAs. It is available from nine suppliers. Additional details are available on the BROMFENAC SODIUM profile page.

The generic ingredient in BROMFENAC SODIUM is bromfenac sodium. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

Summary for 211029

Tradename:	BROMFENAC SODIUM
Applicant:	Gland
Ingredient:	bromfenac sodium
Patents:	0

Pharmacology for NDA: 211029

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 211029

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	211029	ANDA	Gland Pharma Limited	68083-313	68083-313-01	1 BOTTLE, DROPPER in 1 CARTON (68083-313-01) / 1.7 mL in 1 BOTTLE, DROPPER
BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	211029	ANDA	Fosun Pharma USA Inc.	72266-142	72266-142-01	1 BOTTLE, DROPPER in 1 CARTON (72266-142-01) / 1.7 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.09% ACID
Approval Date:	Mar 17, 2020	TE:	AT2	RLD:	No

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