Last Updated: September 27, 2026

Details for New Drug Application (NDA): 214340

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NDA 214340 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 214340

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

Pharmacology for NDA: 214340

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 214340

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	214340	ANDA	Alembic Pharmaceuticals Limited	46708-583	46708-583-03	1 BOTTLE in 1 CARTON (46708-583-03) / 3 mL in 1 BOTTLE
BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	214340	ANDA	Alembic Pharmaceuticals Inc.	62332-583	62332-583-03	1 BOTTLE in 1 CARTON (62332-583-03) / 3 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.07% ACID
Approval Date:	Jul 8, 2024	TE:	AB	RLD:	No

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