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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019404
Company: ALLERGAN

Products on 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OCUFEN	FLURBIPROFEN SODIUM	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019404

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.

Labels for NDA 019404

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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