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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210560

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NDA 210560 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 210560

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

Pharmacology for NDA: 210560

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 210560

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	210560	ANDA	Alembic Pharmaceuticals Limited	46708-508	46708-508-17	1 BOTTLE in 1 CARTON (46708-508-17) / 1.7 mL in 1 BOTTLE
BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	210560	ANDA	Alembic Pharmaceuticals Inc.	62332-508	62332-508-17	1 BOTTLE in 1 CARTON (62332-508-17) / 1.7 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.09% ACID
Approval Date:	Jun 21, 2019	TE:	AT2	RLD:	No

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