Orange Book product · Generic (ANDA)
ADAPALENE
ADAPALENE
At a glance
Jul 01, 2010
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 01, 2010
16 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ADAPALENE
Strength
0.1%
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
ANDA 091314
Product number
001
Marketing status
OTC
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
- 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
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.
