Orange Book product · Brand (NDA)
CYTOXAN
CYCLOPHOSPHAMIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CYCLOPHOSPHAMIDE
Strength
100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 012142
Product number
001
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.
- 2023CYCLOPHOSPHAMIDEBrand (NDA)
NDA 217150 · SANDOZ
- 2023CYCLOPHOSPHAMIDEBrand (NDA)
NDA 217651 · BAXTER HLTHCARE CORP
- 2023FRINDOVYXBrand (NDA)
NDA 210852 · AVYXA HOLDINGS
- 2021CYCLOPHOSPHAMIDEBrand (NDA)
NDA 210735 · EUGIA PHARMA SPECLTS
- 2020CYCLOPHOSPHAMIDEBrand (NDA)
NDA 212501 · DR REDDYS
- 2013CYCLOPHOSPHAMIDEBrand (NDA)
NDA 203856 · HIKMA
- —CYTOXANBrand (NDA)
NDA 012141 · BAXTER HLTHCARE
- 2024CYCLOPHOSPHAMIDEGeneric (ANDA)
ANDA 218632 · HAINAN POLY
- 2024CYCLOPHOSPHAMIDEGeneric (ANDA)
ANDA 218644 · EPIC PHARMA LLC
- 2024CYCLOPHOSPHAMIDEGeneric (ANDA)
ANDA 218282 · EIRGEN
- 2024CYCLOPHOSPHAMIDEGeneric (ANDA)
ANDA 216783 · NEXUS
- 2023CYCLOPHOSPHAMIDEGeneric (ANDA)
ANDA 216958 · HIKMA
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.
