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FDA NDA · NDA020474

VEXOL

Sponsor: HARROW EYE

APPLICATION
NDA020474
TYPE
NDA
ORIGINAL APPROVAL
1994-12-30
LATEST ACTION
2012-02-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued

Products

VEXOLDiscontinued
RIMEXOLONE 1% · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2012-02-22Labeling · Supplement 21 · standard — Letter ↗AP
2007-10-18Labeling · Supplement 19 · standard — Letter ↗AP
2003-04-17Labeling · Supplement 16 · standard — Label ↗AP
2001-03-16Manufacturing (CMC) · Supplement 15 · priorityAP
2000-09-18Manufacturing (CMC) · Supplement 14 · priorityAP
2000-02-18Manufacturing (CMC) · Supplement 13 · priorityAP
1999-11-09Manufacturing (CMC) · Supplement 6 · priorityAP
1999-08-17Manufacturing (CMC) · Supplement 12 · priorityAP
1999-04-07Manufacturing (CMC) · Supplement 11 · priorityAP
1999-03-26Manufacturing (CMC) · Supplement 5 · priorityAP
1999-03-11Manufacturing (CMC) · Supplement 9 · priorityAP
1999-02-05Manufacturing (CMC) · Supplement 10 · priorityAP
1999-01-22Manufacturing (CMC) · Supplement 8 · priorityAP
1998-09-11Labeling · Supplement 7 · standardAP
1998-05-01Manufacturing (CMC) · Supplement 4 · priorityAP
1998-03-20Manufacturing (CMC) · Supplement 3 · priorityAP
1996-08-14Labeling · Supplement 2 · standardAP
1995-05-10Manufacturing (CMC) · Supplement 1 · priorityAP
1994-12-30Type 1 - New Molecular Entity · Original · priorityAP
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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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