Orange Book product · Brand (NDA)
SANDIMMUNE
CYCLOSPORINE
At a glance
Mar 02, 1990
Approved
Brand (NDA)
Application
AB2
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 02, 1990
36 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CYCLOSPORINE
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB2
Application
NDA 050625
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.
- 2023VEVYEBrand (NDA)
NDA 217469 · HARROW EYE
- 2021VERKAZIABrand (NDA)
NDA 214965 · HARROW EYE
- 2018CEQUABrand (NDA)
NDA 210913 · SUN PHARM
- 2002RESTASISBrand (NDA)
NDA 050790 · ABBVIE
- 1995NEORALBrand (NDA)
NDA 050715 · NOVARTIS
- 1995NEORALBrand (NDA)
NDA 050716 · NOVARTIS
- 1983SANDIMMUNEBrand (NDA)
NDA 050573 · NOVARTIS
- 1983SANDIMMUNEBrand (NDA)
NDA 050574 · NOVARTIS
- 2026CYCLOSPORINEGeneric (ANDA)
ANDA 219288 · JIANGSU ANBISON
- 2026CYCLOSPORINEGeneric (ANDA)
ANDA 209064 · TWI PHARMS
- 2025CYCLOSPORINEGeneric (ANDA)
ANDA 211909 · AMNEAL
- 2025CYCLOSPORINEGeneric (ANDA)
ANDA 219049 · QILU
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.
