Orange Book product · Brand (NDA)
CYTOXAN (LYOPHILIZED)
CYCLOPHOSPHAMIDE
At a glance
Aug 30, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 1982
44 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CYCLOPHOSPHAMIDE
Strength
2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
005
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.
