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`Drug Details
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`Drug Name(s)
`FDA Application No.
`Active Ingredient(s)
`Company
`Original Approval or Tentative Approval Date
`Chemical Type
`Review Classification
`
`XIBROM
`(NDA) 021664
`BROMFENAC SODIUM
`BAUSCH AND LOMB INC
`March 24, 2005
`3 New dosage form
`S Standard review drug
`
`(cid:122) There are no Therapeutic Equivalents
`
`(cid:122) Label Information
`
`(cid:122) Approval History, Letters, Reviews, and
`Related Documents
`
`Products on Application (NDA) #021664
` Click on a column header to re-sort the table:
`
`Drug Name Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`BROMDAY
`XIBROM
`
`BROMFENAC SODIUM
`BROMFENAC SODIUM
`
`EQ 0.09% ACID SOLUTION/DROPS;OPHTHALMIC
`EQ 0.09% ACID SOLUTION/DROPS;OPHTHALMIC
`
`RLD TE
`Marketing
`Code
`Status
`Yes AT2
`Prescription
`Discontinued No None
`
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