APPLICATION
ANDA208011
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-19
LATEST ACTION
2024-03-06
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription
Products
AZELAIC ACIDPrescription
AZELAIC ACID 15% · GEL · TOPICAL
Approval history
2024-03-06Labeling · Supplement 3 · standardAP
2024-03-06Labeling · Supplement 4 · standardAP
2018-11-19UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.