APPLICATION
ANDA215505
TYPE
ANDA
ORIGINAL APPROVAL
2025-10-23
LATEST ACTION
2025-10-23
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter
Products
DOCOSANOLOver-the-counter
DOCOSANOL 10% · CREAM · TOPICAL
Approval history
2025-10-23UNKNOWN · 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.