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FDA NDA · NDA020037

VOLTAREN

Sponsor: NOVARTIS

APPLICATION
NDA020037
TYPE
NDA
ORIGINAL APPROVAL
1991-03-28
LATEST ACTION
2012-09-13
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

VOLTAREN · ReferenceDiscontinued
DICLOFENAC SODIUM 0.1% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2012-09-13Labeling · Supplement 31 · standard — Letter ↗AP
2011-04-08Labeling · Supplement 23 · standard — Letter ↗AP
2007-09-04Labeling · Supplement 14 · standard — Label ↗AP
2002-10-01Manufacturing (CMC) · Supplement 17 · priorityAP
2002-04-09Manufacturing (CMC) · Supplement 16 · priorityAP
2001-10-12Manufacturing (CMC) · Supplement 15 · priorityAP
2000-12-26Manufacturing (CMC) · Supplement 13 · priorityAP
2000-10-27Manufacturing (CMC) · Supplement 12 · priorityAP
1998-08-05Manufacturing (CMC) · Supplement 10 · priorityAP
1998-02-25Efficacy · Supplement 8 · standardAP
1997-11-19Manufacturing (CMC) · Supplement 6 · priorityAP
1996-07-23Efficacy · Supplement 7 · standardAP
1995-05-03Labeling · Supplement 5 · standardAP
1995-03-15Manufacturing (CMC) · Supplement 3 · priorityAP
1995-03-15Manufacturing (CMC) · Supplement 4 · priorityAP
1992-12-08Manufacturing (CMC) · Supplement 2 · priorityAP
1992-01-09Labeling · Supplement 1AP
1991-03-28Type 3 - New Dosage Form · Original · priorityAP
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