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FDA NDA · NDA020428

AZELEX

azelaic acid

Sponsor: ALMIRALL

APPLICATION
NDA020428
TYPE
NDA
ORIGINAL APPROVAL
1995-09-13
LATEST ACTION
2024-02-20
ROUTE
CUTANEOUS, TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

AZELEX · ReferencePrescription
AZELAIC ACID 20% · CREAM · TOPICAL

Approval history

2024-02-20Manufacturing (CMC) · Supplement 27 · standard — Label ↗AP
2020-01-06Labeling · Supplement 22 · standard — Letter ↗AP
2003-06-10Labeling · Supplement 16 · standard — Label ↗AP
2002-02-19Manufacturing (CMC) · Supplement 15 · standardAP
2001-04-27Labeling · Supplement 13 · standard — Label ↗AP
2000-04-05Manufacturing (CMC) · Supplement 12 · standardAP
1999-11-10Manufacturing (CMC) · Supplement 10 · standardAP
1999-11-10Manufacturing (CMC) · Supplement 11 · standardAP
1998-09-04Manufacturing (CMC) · Supplement 8 · standardAP
1998-09-04Manufacturing (CMC) · Supplement 6 · standardAP
1997-09-23Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
1997-06-29Manufacturing (CMC) · Supplement 5 · standardAP
1996-11-27Manufacturing (CMC) · Supplement 4 · standardAP
1996-05-17Manufacturing (CMC) · Supplement 2 · standardAP
1996-05-17Manufacturing (CMC) · Supplement 3 · standardAP
1996-05-17Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1995-09-13Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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