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`Drug Name(s)
`FDA Application No.
`Active Ingredient(s)
`Company
`Original Approval or Tentative Approval Date
`Chemical Type
`Review Classification
`
`PROLENSA
`(NDA) 203168
`BROMFENAC SODIUM
`BAUSCH AND LOMB
`April 5, 2013
`5 New formulation or new manufacturer
`S Standard review drug
`
`There are no Therapeutic Equivalents
`
`Label Information
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`Approval History, Letters, Reviews, and Related
`Documents
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`Products on Application (NDA) #203168
` Click on a column header to resort the table:
`
`Drug Name Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`PROLENSA
`
`BROMFENAC SODIUM
`
`EQ 0.07% ACID
`
`SOLUTION/DROPS;OPHTHALMIC
`
`RLD TE
`Marketing
`Code
`Status
`Prescription Yes None
`
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