← FDA DRUG APPROVALS

FDA NDA · NDA022320

EPIDUO

Sponsor: GALDERMA LABS LP

APPLICATION
NDA022320
TYPE
NDA
ORIGINAL APPROVAL
2008-12-08
LATEST ACTION
2014-08-01
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

EPIDUO · ReferenceDiscontinued
ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% · GEL · TOPICAL

Approval history

2014-08-01Manufacturing (CMC) · Supplement 8 · standardAP
2014-07-01Manufacturing (CMC) · Supplement 7 · standardAP
2013-02-15Manufacturing (CMC) · Supplement 5 · standardAP
2013-02-01Efficacy · Supplement 4 · standard — Label ↗AP
2011-12-14Labeling · Supplement 2 · unknown — Label ↗AP
2011-02-18Labeling · Supplement 1 · unknown — Label ↗AP
2008-12-08Type 4 - New Combination · 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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