APPLICATION
ANDA090962
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-02
LATEST ACTION
2026-03-10
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Over-the-counter
Products
ADAPALENEOver-the-counter
ADAPALENE 0.1% · GEL · TOPICAL
Approval history
2026-03-10Manufacturing (CMC) · Supplement 8 · unknownAP
2019-07-08Manufacturing (CMC) · Supplement 5 · unknownAP
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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