Orange Book product · Generic (ANDA)
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
At a glance
Aug 19, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 19, 2019
6 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Strength
2.5%;EQ 1.2% BASE
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
ANDA 207194
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
- 2008ACANYABrand (NDA)
NDA 050819 · BAUSCH
- 2002DUACBrand (NDA)
NDA 050741 · STIEFEL
- 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 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.
