← FDA DRUG APPROVALS

FDA NDA · NDA020380

DIFFERIN

adapalene

Sponsor: GALDERMA LABS LP

APPLICATION
NDA020380
TYPE
NDA
ORIGINAL APPROVAL
1996-05-31
LATEST ACTION
2022-06-14
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Over-the-counter

Products

DIFFERIN · ReferenceOver-the-counter
ADAPALENE 0.1% · GEL · TOPICAL

Approval history

2022-06-14Labeling · Supplement 21 · standard — Letter ↗AP
2018-03-23Labeling · Supplement 13 · standard — Label ↗AP
2017-05-19Labeling · Supplement 11 · standard — Letter ↗AP
2016-07-08Efficacy · Supplement 10 · standard — Label ↗AP
2007-09-05Manufacturing (CMC) · Supplement 4AP
1996-05-31Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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