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Serving 500+ biopharmaceutical companies globally:

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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203395

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NDA 203395 describes BROMFENAC SODIUM, which is a drug marketed by Coastal Pharms, Apotex Inc, Amring Pharms, Paddock Llc, and Hi-tech Pharmacal, and is included in six NDAs. It is available from five suppliers. Additional details are available on the BROMFENAC SODIUM profile page.

The generic ingredient in BROMFENAC SODIUM is bromfenac sodium. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

Summary for NDA: 203395

Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 203395

Suppliers and Packaging for NDA: 203395

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC 203395 ANDA Hi-Tech Pharmacal Co., Inc. 50383-249 50383-249-71 1 BOTTLE, DROPPER in 1 CARTON (50383-249-71) > 1.7 mL in 1 BOTTLE, DROPPER

Summary 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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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Queensland Health
Express Scripts
Johnson and Johnson
Fish and Richardson

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