Orange Book product · Brand (NDA)
DUAC
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
At a glance
Aug 26, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 26, 2002
24 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Strength
5%;1.2%
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
NDA 050741
Product number
001
Marketing status
RX
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.
- 2008ACANYABrand (NDA)
NDA 050819 · BAUSCH
- 2000BENZACLINBrand (NDA)
NDA 050756 · BAUSCH
- 2024CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 209610 · PADAGIS ISRAEL
- 2021CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 212433 · ENCUBE
- 2019CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 205397 · PADAGIS ISRAEL
- 2019CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 207194 · ENCUBE
- 2019CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 206575 · SUN PHARMA CANADA
- 2019CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 209252 · GLENMARK SPECLT
- 2018CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 210794 · ZYDUS PHARMS
- 2018CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 208683 · SUN PHARMA CANADA
- 2018CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 208776 · SUN PHARMA CANADA
- 2017CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 206218 · SUN PHARMA CANADA
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.
