Last Updated: September 24, 2026

Details for New Drug Application (NDA): 203395

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NDA 203395 describes BROMFENAC SODIUM, which is a drug marketed by Alembic, Amneal, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland, J Molner, Lupin, 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. 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 203395

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

Pharmacology for NDA: 203395

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 203395

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203395	ANDA	ARMAS PHARMACEUTICALS INC.	72485-649	72485-649-71	1 BOTTLE, DROPPER in 1 CARTON (72485-649-71) / 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:	Jan 22, 2014	TE:	AT2	RLD:	No

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