Last Updated: November 12, 2026

Details for New Drug Application (NDA): 211029

« Back to Dashboard

NDA 211029 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.