Orange Book product · Brand (NDA)
CLINDESSE
CLINDAMYCIN PHOSPHATE
At a glance
Nov 30, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 2004
21 yr 10 mo ago
Today
Patent 9789057 expires
Listed drug product patent expiration.
Dec 02, 2026
in 6 mo
Pharmaceutical detail
Active ingredient
CLINDAMYCIN PHOSPHATE
Strength
EQ 2% BASE
Dosage form
CREAM
Route
VAGINAL
TE code
Not listed
Application
NDA 050793
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
- 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
- 2022CLINDAMYCIN PHOSPHATEGeneric (ANDA)
ANDA 214668 · AMNEAL
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9789057 | Dec 02, 2026 | in 6 mo | ProductU-137 |
