Orange Book product · Brand (NDA)
BENZACLIN
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
At a glance
Apr 20, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 20, 2007
19 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Strength
5%;EQ 1% BASE
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
NDA 050756
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2008ACANYABrand (NDA)
NDA 050819 · BAUSCH
- 2002DUACBrand (NDA)
NDA 050741 · STIEFEL
- 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.

