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FDA NDA · NDA021753

ADAPALENE

Sponsor: GALDERMA LABS LP

APPLICATION
NDA021753
TYPE
NDA
ORIGINAL APPROVAL
2007-06-19
LATEST ACTION
2023-12-27
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

DIFFERIN · ReferencePrescription
ADAPALENE 0.3% · GEL · TOPICAL

Approval history

2023-12-27Labeling · Supplement 18 · standard — Letter ↗AP
2023-12-27Labeling · Supplement 14 · standard — Letter ↗AP
2022-08-25Labeling · Supplement 11 · standard — Letter ↗AP
2014-06-13Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2012-02-27Manufacturing (CMC) · Supplement 4 — Label ↗AP
2010-09-01Labeling · Supplement 2 · unknown — Label ↗AP
2007-06-19Type 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.

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