Orange Book product · Brand (NDA)
NEORAL
CYCLOSPORINE
At a glance
Jul 14, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 14, 1995
31 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CYCLOSPORINE
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 050715
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 050716 · NOVARTIS
- 1990SANDIMMUNEBrand (NDA)
NDA 050625 · 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.
