Orange Book product · Brand (NDA)
CLEOCIN T
CLINDAMYCIN PHOSPHATE
At a glance
Jan 07, 1987
Approved
Brand (NDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 07, 1987
40 yr ago
Today
Pharmaceutical detail
Active ingredient
CLINDAMYCIN PHOSPHATE
Strength
EQ 1% BASE
Dosage form
GEL
Route
TOPICAL
TE code
AB1
Application
NDA 050615
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
- —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.
