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Orange Book product · Brand (NDA)

DIFFERIN

ADAPALENE

Brand (NDA)NDA 020380OTC GALDERMA LABS LP
View ADAPALENE familyOpen on FDA Orange Book

At a glance

Jul 08, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 08, 2016

    10 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ADAPALENE

Strength

0.1%

Dosage form

GEL

Route

TOPICAL

TE code

Not listed

Application

NDA 020380

Product number

002

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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