Orange Book product · Generic (ANDA)
ADAPALENE
ADAPALENE
At a glance
Jun 18, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 18, 2020
6 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ADAPALENE
Strength
0.3%
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
ANDA 213508
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ADAPALENE
- 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
- 1996DIFFERINBrand (NDA)
NDA 020338 · GALDERMA LABS LP
- 2022ADAPALENEGeneric (ANDA)
ANDA 215940 · SUN PHARMA CANADA
- 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.
