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UBS
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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021664

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NDA 021664 describes XIBROM, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from one supplier. Additional details are available on the XIBROM profile page.

The generic ingredient in XIBROM is bromfenac sodium. Four suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for 021664
Tradename:XIBROM
Applicant:Bausch And Lomb Inc
Ingredient:bromfenac sodium
Patents:0
Therapeutic Class:Ophthalmic Agents
Pharmacology for NDA: 021664
Suppliers and Packaging for NDA: 021664
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROMDAY bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 021664 NDA Unit Dose Services 50436-6301 N 50436-6301-0
XIBROM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 021664 NDA Unit Dose Services 50436-6301 N 50436-6301-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 24, 2005TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 16, 2010TE:RLD:Yes

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Citi
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Queensland Health
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