FDA NDA · NDA020809

DICLOFENAC SODIUM

Sponsor: FALCON PHARMS

APPLICATION

NDA020809

TYPE

NDA

ORIGINAL APPROVAL

1998-05-04

LATEST ACTION

2002-03-13

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Discontinued

Products

DICLOFENAC SODIUMDiscontinued

DICLOFENAC SODIUM 0.1% · SOLUTION/DROPS · OPHTHALMIC

2002-03-13Manufacturing (CMC) · Supplement 9 · standardAP

2001-03-16Manufacturing (CMC) · Supplement 8 · standardAP

2000-02-18Manufacturing (CMC) · Supplement 7 · standardAP

1999-12-17Manufacturing (CMC) · Supplement 5 · standardAP

1999-10-06Manufacturing (CMC) · Supplement 3 · standardAP

1999-08-17Manufacturing (CMC) · Supplement 4 · standardAP

1999-02-05Manufacturing (CMC) · Supplement 2 · standardAP

1998-11-02Manufacturing (CMC) · Supplement 1 · standardAP

1998-05-04Type 3 - New Dosage Form · Original · standard — Review ↗AP

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.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.