Drugs@FDA: FDA-Approved Drugs

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	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