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FDA NDA · NDA020723

ALDARA

Sponsor: BAUSCH

APPLICATION
NDA020723
TYPE
NDA
ORIGINAL APPROVAL
1997-02-27
LATEST ACTION
2024-09-25
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

ALDARA · ReferenceDiscontinued
IMIQUIMOD 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2024-09-25Labeling · Supplement 28 · standard — Label ↗AP
2015-02-03Manufacturing (CMC) · Supplement 26 · standardAP
2014-11-26Manufacturing (CMC) · Supplement 25 · standardAP
2010-10-14Labeling · Supplement 22 · unknown — Letter ↗AP
2007-03-22Efficacy · Supplement 20 · priority — Label ↗AP
2005-08-09Labeling · Supplement 18 · standard — Label ↗AP
2004-07-14Efficacy · Supplement 16 · unknown — Label ↗AP
2004-03-02Efficacy · Supplement 15 · standard — Label ↗AP
2002-12-15Labeling · Supplement 10 · standard — Letter ↗AP
2002-09-03Labeling · Supplement 12 · standard — Letter ↗AP
2002-09-03Labeling · Supplement 11 · standard — Label ↗AP
2001-12-08Labeling · Supplement 1 · standard — Review ↗AP
2001-03-28Manufacturing (CMC) · Supplement 9 · standardAP
2000-09-27Manufacturing (CMC) · Supplement 8 · standardAP
2000-03-07Manufacturing (CMC) · Supplement 7 · standardAP
2000-03-07Manufacturing (CMC) · Supplement 6 · standardAP
1998-02-20Manufacturing (CMC) · Supplement 4 · standardAP
1997-12-08Manufacturing (CMC) · Supplement 3 · standardAP
1997-11-07Manufacturing (CMC) · Supplement 2 · standardAP
1997-02-27Type 1 - New Molecular Entity · Original · standardAP
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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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