Orange Book product · Brand (NDA)
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
At a glance
Sep 16, 2013
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 16, 2013
12 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CYCLOPHOSPHAMIDE
Strength
50MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 203856
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.
- 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
- —CYTOXANBrand (NDA)
NDA 012142 · BAXTER HLTHCARE
- —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.
