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FDA NDA · NDA021470

AZELAIC ACID GEL

azelaic acid

Sponsor: LEO PHARMA AS

APPLICATION
NDA021470
TYPE
NDA
ORIGINAL APPROVAL
2002-12-24
LATEST ACTION
2021-11-01
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

FINACEA · ReferencePrescription
AZELAIC ACID 15% · GEL · TOPICAL

Approval history

2021-11-01Labeling · Supplement 17 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 15 · standard — Label ↗AP
2020-11-27Labeling · Supplement 16 · standard — Label ↗AP
2016-08-05Labeling · Supplement 13 · standard — Letter ↗AP
2015-12-28Labeling · Supplement 12 · standard — Label ↗AP
2015-04-03Labeling · Supplement 10 · standard — Letter ↗AP
2015-02-03Manufacturing (CMC) · Supplement 9 · standardAP
2014-10-23Manufacturing (CMC) · Supplement 8 · standardAP
2012-12-18Labeling · Supplement 7 · unknown — Label ↗AP
2010-10-25Labeling · Supplement 5 · standard — Label ↗AP
2005-05-05Efficacy · Supplement 3 · standard — Letter ↗AP
2002-12-24Type 3 - New Dosage Form · Original · standard — Label ↗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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