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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
`
`OCUFEN
`(NDA) 019404
`FLURBIPROFEN SODIUM
`ALLERGAN
`December 31, 1986
`1 New molecular entity (NME)
`P Priority review drug
`
`(cid:122) Therapeutic Equivalents
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`(cid:122) Label Information
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`(cid:122) Approval History, Letters, Reviews, and
`Related Documents
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`Products on Application (NDA) #019404
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`Drug Name Active Ingredients
`
`Strength Dosage Form/Route
`
`OCUFEN
`
`FLURBIPROFEN SODIUM
`
`0.03%
`
`SOLUTION/DROPS;OPHTHALMIC
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`Marketing
`Status
`Prescription
`
`RLD TE
`Code
`Yes AT
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