Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019404
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCUFEN FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/31/1986 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019404Orig1s000rev.pdf
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019404s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019404Orig1s026ltr.pdf
04/12/2002 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/2003 SUPPL-20 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19404scp020_ocufen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19404scp020ltr.pdf
11/27/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/17/2001 SUPPL-17 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19404s17lbl.pdf
04/12/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/30/2001 SUPPL-14 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19404s14lbl.pdf
10/02/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/29/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1992 SUPPL-7 Labeling

Label is not available on this site.

04/13/1989 SUPPL-5 Labeling

Label is not available on this site.

07/25/1990 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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

OCUFEN

SOLUTION/DROPS;OPHTHALMIC; 0.03%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLURBIPROFEN SODIUM FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074447 BAUSCH AND LOMB
OCUFEN FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019404 ALLERGAN

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