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FDA NDA · NDA022502

DIFFERIN

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APPLICATION
NDA022502
TYPE
NDA
ORIGINAL APPROVAL
2010-03-17
LATEST ACTION
2023-04-19
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

DIFFERIN · ReferenceDiscontinued
ADAPALENE 0.1% · LOTION · TOPICAL

Approval history

2023-04-19Labeling · Supplement 10 · standardLabelAP
2022-08-24Labeling · Supplement 8 · standardLabelAP
2014-09-30Manufacturing (CMC) · Supplement 5 · standardAP
2014-05-29Manufacturing (CMC) · Supplement 4 · standardAP
2013-04-19Labeling · Supplement 3 · standardLabelAP
2010-03-17Type 3 - New Dosage Form · Original · standardLabelAP
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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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