Orange Book product · Brand (NDA)
DIFFERIN
ADAPALENE
At a glance
May 31, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 31, 1996
30 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ADAPALENE
Strength
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 020338
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2016DIFFERINBrand (NDA)
NDA 020380 · GALDERMA LABS LP
- 2010DIFFERINBrand (NDA)
NDA 022502 · GALDERMA LABS LP
- 2007DIFFERINBrand (NDA)
NDA 021753 · GALDERMA LABS LP
- 2000DIFFERINBrand (NDA)
NDA 020748 · GALDERMA LABS LP
- 2022ADAPALENEGeneric (ANDA)
ANDA 215940 · SUN PHARMA CANADA
- 2020ADAPALENEGeneric (ANDA)
ANDA 213508 · ALEMBIC
- 2016ADAPALENEGeneric (ANDA)
ANDA 203981 · WAYLIS THERAP
- 2016ADAPALENEGeneric (ANDA)
ANDA 208322 · SUN PHARMA CANADA
- 2016ADAPALENEGeneric (ANDA)
ANDA 204593 · WAYLIS THERAP
- 2014ADAPALENEGeneric (ANDA)
ANDA 201000 · ACTAVIS MID ATLANTIC
- 2012ADAPALENEGeneric (ANDA)
ANDA 200298 · ENCUBE ETHICALS
- 2010ADAPALENEGeneric (ANDA)
ANDA 091314 · GLENMARK PHARMS
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.
