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FDA NDA · NDA019404

OCUFEN

Sponsor: ALLERGAN

APPLICATION
NDA019404
TYPE
NDA
ORIGINAL APPROVAL
1986-12-31
LATEST ACTION
2012-07-25
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

OCUFEN · ReferenceDiscontinued
FLURBIPROFEN SODIUM 0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2012-07-25Labeling · Supplement 26 · standard — Letter ↗AP
2003-08-25Manufacturing (CMC) · Supplement 20 · priority — Letter ↗AP
2002-04-12Manufacturing (CMC) · Supplement 21 · priorityAP
2001-12-04Manufacturing (CMC) · Supplement 18 · priorityAP
2001-11-27Manufacturing (CMC) · Supplement 19 · priorityAP
2001-08-17Manufacturing (CMC) · Supplement 17 · priority — Label ↗AP
2001-07-30Labeling · Supplement 14 · standard — Label ↗AP
2001-04-12Manufacturing (CMC) · Supplement 16 · priorityAP
2000-10-02Manufacturing (CMC) · Supplement 13 · priorityAP
1998-04-29Manufacturing (CMC) · Supplement 12 · priorityAP
1997-04-18Manufacturing (CMC) · Supplement 11 · priorityAP
1996-06-10Manufacturing (CMC) · Supplement 10 · priorityAP
1995-08-03Manufacturing (CMC) · Supplement 9 · priorityAP
1992-04-21Labeling · Supplement 7AP
1990-07-25Manufacturing (CMC) · Supplement 1 · priorityAP
1989-04-13Labeling · Supplement 5AP
1986-12-31Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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