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Fish and Richardson
US Army
Daiichi Sankyo

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201211

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NDA 201211 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. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for 201211
Applicant:Coastal Pharms
Ingredient:bromfenac sodium
Therapeutic Class:Ophthalmic Agents
Pharmacology for NDA: 201211
Suppliers and Packaging for NDA: 201211
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 201211 ANDA Physicians Total Care, Inc. 54868-6343 E 54868-6343-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.09% ACID
Approval Date:May 11, 2011TE:RLD:No

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