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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019404
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCUFEN FLURBIPROFEN SODIUM 0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019404s026lbl.pdf
08/25/2003 SUPPL-20 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19404scp020_ocufen_lbl.pdf
08/17/2001 SUPPL-17 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19404s17lbl.pdf
07/30/2001 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19404s14lbl.pdf
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