Orange Book product · Brand (NDA)
CLEOCIN
CLINDAMYCIN PHOSPHATE
At a glance
Aug 13, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 13, 1999
27 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CLINDAMYCIN PHOSPHATE
Strength
100MG
Dosage form
SUPPOSITORY
Route
VAGINAL
TE code
Not listed
Application
NDA 050767
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.
- 2021XACIATOBrand (NDA)
NDA 215650 · ORGANON LLC
- 2004CLINDESSEBrand (NDA)
NDA 050793 · PADAGIS US
- 2004EVOCLINBrand (NDA)
NDA 050801 · NORVIUM BIOSCIENCE
- 2000CLINDAGELBrand (NDA)
NDA 050782 · BAUSCH
- 1992CLEOCINBrand (NDA)
NDA 050680 · PFIZER
- 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
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.
