← FDA DRUG APPROVALS

FDA NDA · NDA020748

ADAPALENE

Sponsor: GALDERMA LABS LP

APPLICATION
NDA020748
TYPE
NDA
ORIGINAL APPROVAL
2000-05-26
LATEST ACTION
2014-08-01
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

DIFFERIN · ReferencePrescription
ADAPALENE 0.1% · CREAM · TOPICAL

Approval history

2014-08-01Manufacturing (CMC) · Supplement 9 · standardAP
2013-02-08Manufacturing (CMC) · Supplement 8 · standardAP
2001-09-25Manufacturing (CMC) · Supplement 1 · standardAP
2000-05-26Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →