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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 203395


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NDA 203395 describes BROMFENAC SODIUM, which is a drug marketed by Alembic, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Rising, and Sentiss, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the BROMFENAC SODIUM profile page.

The generic ingredient in BROMFENAC SODIUM is bromfenac sodium. Ten 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 ActionCyclooxygenase 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:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.09% ACID
Approval Date:Jan 22, 2014TE:AT2RLD:No

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