Orange Book product · Brand (NDA)
EPIDUO FORTE
ADAPALENE; BENZOYL PEROXIDE
At a glance
Jul 15, 2015
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 15, 2015
11 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ADAPALENE; BENZOYL PEROXIDE
Strength
0.3%;2.5%
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
NDA 207917
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2026DIFFERIN EPIDUOBrand (NDA)
NDA 220736 · GALDERMA LABS LP
- 2008EPIDUOBrand (NDA)
NDA 022320 · GALDERMA LABS LP
- 2022ADAPALENE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 214185 · ALEMBIC
- 2022ADAPALENE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 209641 · ACTAVIS LABS UT INC
- 2022ADAPALENE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 214553 · ZYDUS PHARMS
- 2022ADAPALENE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 212464 · PADAGIS ISRAEL
- 2019ADAPALENE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 208108 · GLENMARK PHARMS LTD
- 2018ADAPALENE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 209148 · SUN PHARMA CANADA
- 2018ADAPALENE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 206164 · ENCUBE
- 2018ADAPALENE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 206959 · SUN PHARMA CANADA
- 2018ADAPALENE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 205033 · PADAGIS ISRAEL
- 2015ADAPALENE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 203790 · ACTAVIS MID ATLANTIC
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.
