Orange Book product · Brand (NDA)
CLEOCIN
CLINDAMYCIN PHOSPHATE
At a glance
Mar 02, 1998
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 02, 1998
28 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
CLINDAMYCIN PHOSPHATE
Strength
EQ 2% BASE
Dosage form
CREAM
Route
VAGINAL
TE code
AB
Application
NDA 050680
Product number
002
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.
- 2021XACIATOBrand (NDA)
NDA 215650 · ORGANON LLC
- 2004CLINDESSEBrand (NDA)
NDA 050793 · PADAGIS US
- 2004EVOCLINBrand (NDA)
NDA 050801 · NORVIUM BIOSCIENCE
- 2000CLINDAGELBrand (NDA)
NDA 050782 · BAUSCH
- 1989CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 050639 · PFIZER
- 1987CLEOCIN TBrand (NDA)
NDA 050615 · PFIZER
- —CLEOCIN PHOSPHATEBrand (NDA)
NDA 050441 · PFIZER
- 2026CLINDAMYCIN PHOSPHATEGeneric (ANDA)
ANDA 218942 · AUROBINDO PHARMA LTD
- 2024CLINDAMYCIN PHOSPHATEGeneric (ANDA)
ANDA 212466 · ALEMBIC
- 2023CLINDAMYCIN PHOSPHATEGeneric (ANDA)
ANDA 216587 · ZYDUS LIFESCIENCES
- 2022CLINDAMYCIN PHOSPHATEGeneric (ANDA)
ANDA 215219 · AMNEAL
- 2022CLINDAMYCIN PHOSPHATEGeneric (ANDA)
ANDA 214668 · AMNEAL
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.
