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Medtronic
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Generated: May 20, 2018

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 Amring Pharms, Apotex Inc, Coastal Pharms, Hi-tech Pharmacal, and Paddock Llc, and is included in six NDAs. It is available from two suppliers. Additional details are available on the BROMFENAC SODIUM profile page.

The generic ingredient in BROMFENAC SODIUM is bromfenac sodium. Five suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for 203395
Tradename:BROMFENAC SODIUM
Applicant:Hi-tech Pharmacal
Ingredient:bromfenac sodium
Patents:0
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 bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203395 ANDA Hi-Tech Pharmacal Co., Inc. 50383-249 N 50383-249-71

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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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Teva
Fish and Richardson
Chubb
US Department of Justice
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Queensland Health
Federal Trade Commission
UBS

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