Last Updated: September 27, 2026

Details for New Drug Application (NDA): 201211

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NDA 201211 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 201211

Tradename:	BROMFENAC SODIUM
Applicant:	Coastal Pharms
Ingredient:	bromfenac sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.09% ACID
Approval Date:	May 11, 2011	TE:		RLD:	No

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