Active substance
Cyclophosphamide
- SFDA 7
- US FDA 33
- Health Canada 12
- US price lines 2
- WHO EML 1
- Safety 7
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ENDOXAN SUGAR COATED TABLET | 50 mg | Film-coated tablet · Oral use | 50 Blister | SAR 48.45 | NCE · Prescription | Baxter Deutschland GmbH | Valid |
| ENDOXAN. VIAL 1 GM. | 1 g | powder for solution for injection · Intravenous use | 1 Vial | SAR 64.75 | NCE · Prescription | Baxter Deutschland GmbH | Valid |
| ENDOXAN. VIAL 200 MG | 200 mg | powder for solution for injection · Intravenous use | 1 Vial | SAR 14.65 | NCE · Prescription | Baxter Deutschland GmbH | Valid |
| ENDOXAN. VIAL 500 MG | 500 mg | powder for solution for injection · Intravenous use | 1 Vial | SAR 35.30 | NCE · Prescription | Baxter Deutschland GmbH | Valid |
| CYCLOPHOSPHAMIDE 1000MG VIAL | 1 g | Solution for injection · Intravenous use | 10 Vial | SAR 186.40 | Generic · Prescription | ORION PHARMA | Withdrawn by MAH · Not Marketed |
| CYCLOPHOSPHAMIDE 100MG VIAL | 100 mg | Solution for injection · Intravenous use | 10 Vial | SAR 37.15 | Generic · Prescription | ORION PHARMA | Withdrawn by MAH · Not Marketed |
| CYCLOPHOSPHAMIDE 200MG VIAL | 200 mg | Solution for injection · Intravenous use | 10 Vial | SAR 46.70 | Generic · Prescription | ORION PHARMA | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ACQUIRED HEMOPHILIA; ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); AMYLOIDOSIS - LIGHT CHAIN; BONE SARCOMAS; BRAIN CANCERS; BREAST CANCER EARLY HER-2 -VE; BREAST CANCER HER-2 +VE; BREAST CANCER MET.HER-2 -VE; BURKITT`S LYMPHOMA; CASTLEMAN DISEASE; CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; GLOMERULAR DISEASE; GRANULOMATOSIS WITH POLYANGIITIS AND MICROSCOPIC POLYANGIITIS; HODGKIN'S LYMPHOMA; IMMUNE THROMBOCYPTOPENIC PUPURA; LICHEN PLANUS; LYMPHOPLASMACYTIC LYMPHOMA; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA; MULTIPLE SCLEROSIS; MYASTHENIA GRAVIS; MYOSITIS; Neuroblastoma; OVARIAN CANCER; PARATHYROID CANCER; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL); PEDIATRIC B-CELL LYMPHOMA; PEMPHIGUS; RETINOBLASTOMA; SARCOIDOSIS; SJOGREN'S SYNDROME; SMALL CELL LUNG CANCER (SCLC); SYSTEMIC LUPUS ERYTHEMATOSUS; T-CELL LYMPHOMA; THROMBOTIC THROMBOCYTOPENIC PURPURA; WILMS TUMOR
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CYTOXAN | 50MG; 25MG | tablet · oral | BAXTER HLTHCARE | Prescription | 16 Nov 1959 |
| CYCLOPHOSPHAMIDE | 500MG/VIAL; 1GM/VIAL; 2GM/VIAL | injectable · injection | BAXTER HLTHCARE | Prescription | 21 May 2008 |
| CYCLOPHOSPHAMIDE | 25MG; 50MG | capsule · oral | HIKMA PHARMS | Prescription | 16 Sep 2013 |
| CYCLOPHOSPHAMIDE | 500MG/VIAL; 1GM/VIAL; 2GM/VIAL | injectable · injection | HENGRUI PHARMA | Prescription | 31 Oct 2014 |
| CYCLOPHOSPHAMIDE | 25MG; 50MG | capsule · oral | SENORES PHARMS | Prescription | 7 May 2018 |
| CYCLOPHOSPHAMIDE | 500MG/VIAL; 1GM/VIAL; 2GM/VIAL | injectable · injection | AMNEAL | Prescription | 25 May 2018 |
| CYCLOPHOSPHAMIDE | 25MG; 50MG | capsule · oral | CIPLA | Prescription | 18 Jan 2019 |
| CYCLOPHOSPHAMIDE | 500MG/2.5ML (200MG/ML); 1GM/5ML (200MG/ML); 2GM/10ML (200MG/ML) | solution · intravenous | DR REDDYS | Prescription | 30 Jul 2020 |
| CYCLOPHOSPHAMIDE | 500MG/2.5ML (200MG/ML); 1GM/5ML (200MG/ML); 2GM/10ML (200MG/ML) | solution · intravenous | EUGIA PHARMA SPECLTS | Prescription | 25 Aug 2021 |
| CYCLOPHOSPHAMIDE | 500MG/VIAL; 1GM/VIAL; 2GM/VIAL | injectable · injection | XGEN PHARMS | Prescription | 18 Oct 2022 |
| CYCLOPHOSPHAMIDE | 25MG; 50MG | capsule · oral | ALEMBIC | Prescription | 10 Nov 2022 |
| FRINDOVYX | 500MG/ML (500MG/ML); 1GM/2ML (500MG/ML); 2GM/4ML (500MG/ML) | solution · intravenous | AVYXA HOLDINGS | Prescription | 7 Jun 2023 |
| CYCLOPHOSPHAMIDE | 500MG/2.5ML (200MG/ML); 1GM/5ML (200MG/ML) | solution · intravenous | BAXTER HLTHCARE CORP | Prescription | 27 Jun 2023 |
| CYCLOPHOSPHAMIDE | 500MG/VIAL; 1GM/VIAL; 2GM/VIAL | injectable · injection | SAGENT PHARMS INC | Prescription | 17 Jul 2023 |
| CYCLOPHOSPHAMIDE | 500MG/5ML (100MG/ML); 1GM/10ML (100MG/ML); 2GM/20ML (100MG/ML) | solution · intravenous | SANDOZ | Prescription | 12 Sep 2023 |
| CYCLOPHOSPHAMIDE | 500MG/VIAL; 1GM/VIAL; 2GM/VIAL | injectable · injection | SUNNY | Prescription | 26 Oct 2023 |
| CYCLOPHOSPHAMIDE | 25MG; 50MG | capsule · oral | ZYDUS LIFESCIENCES | Prescription | 13 Dec 2023 |
| CYCLOPHOSPHAMIDE | 500MG/VIAL; 1GM/VIAL; 2GM/VIAL | injectable · injection | HIKMA PHARMS | Prescription | 18 Dec 2023 |
| CYCLOPHOSPHAMIDE | 500MG/2.5ML (200MG/ML); 1GM/5ML (200MG/ML) | solution · intravenous | NEXUS | Prescription | 29 Oct 2024 |
| CYCLOPHOSPHAMIDE | 25MG; 50MG | capsule · oral | EIRGEN | Prescription | 3 Dec 2024 |
| CYCLOPHOSPHAMIDE | 500MG/VIAL; 1GM/VIAL; 2GM/VIAL | injectable · injection | EPIC PHARMA LLC | Prescription | 19 Dec 2024 |
| CYCLOPHOSPHAMIDE | 500MG/VIAL; 1GM/VIAL; 2GM/VIAL | injectable · injection | HAINAN POLY | Prescription | 26 Dec 2024 |
| CYTOXAN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | BAXTER HLTHCARE | Discontinued | 16 Nov 1959 |
| CYTOXAN (LYOPHILIZED) | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | BAXTER HLTHCARE | Discontinued | 16 Nov 1959 |
| LYOPHILIZED CYTOXAN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | BAXTER HLTHCARE | Discontinued | 16 Nov 1959 |
8 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| CYCLOPHOSPHAMIDE FOR INJECTION USP | 02546736 | 1000 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | ANDONE PHARMACEUTICAL INC |
| CYCLOPHOSPHAMIDE FOR INJECTION USP | 02546744 | 2000 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | ANDONE PHARMACEUTICAL INC |
| CYCLOPHOSPHAMIDE FOR INJECTION USP | 02547686 | 1000 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | STERIMAX INC |
| CYCLOPHOSPHAMIDE FOR INJECTION USP | 02547694 | 2000 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | STERIMAX INC |
| CYCLOPHOSPHAMIDE FOR INJECTION USP | 02560216 | 1000 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | MARCAN PHARMACEUTICALS INC |
| CYCLOPHOSPHAMIDE FOR INJECTION USP | 02560224 | 2000 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | MARCAN PHARMACEUTICALS INC |
| PROCYTOX | 02241795 | 25 MG | TABLET · ORAL | BAXTER CORPORATION |
| PROCYTOX | 02241796 | 50 MG | TABLET · ORAL | BAXTER CORPORATION |
| PROCYTOX | 02241797 | 200 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | BAXTER CORPORATION |
| PROCYTOX | 02241798 | 500 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | BAXTER CORPORATION |
| PROCYTOX | 02241799 | 1000 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | BAXTER CORPORATION |
| PROCYTOX | 02241800 | 2000 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | BAXTER CORPORATION |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | CYCLOPHOSPHAMIDE 25 MG CAPSULE | $1.12118 | per EA | 18 Feb 2026 |
| US NADAC | CYCLOPHOSPHAMIDE 50 MG CAPSULE | $1.67057 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 8.2.1. Cytotoxic medicines · complementary
Diffuse large B-cell lymphoma, not otherwise specified; Chronic lymphocytic leukaemia or small lymphocytic lymphoma; Plasma cell myeloma; Burkitt lymphoma including Burkitt leukaemia; Lymphoid leukaemia, not elsewhere classified; Other specified gliomas of brain; Anaplastic large cell lymphoma, ALK-negative; Anaplastic large cell lymphoma, ALK-positive; Rhabdomyosarcoma primary site; Malignant neoplasms of breast; Other specified malignant neoplasms of breast; Hodgkin lymphoma; Malignant trophoblastic neoplasms of placenta; Follicular lymphoma; Ewing sarcoma of bone or articular cartilage of unspecified sites; Malignant neoplasms of kidney, except renal pelvis
Parenteral > General injections > IV: 500 mg in vial powder for injection; 1 g in vial powder for injection; 2 g in vial powder for injection | Oral > Solid > dosage form: 25 mg; 50 mg
Safety signals and safety-related labeling changes
- US FDA 24 Jan 2025 FRINDOVYX — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 30 Dec 2024 CYCLOPHOSPHAMIDE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Sep 2024 CYTOXAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Sep 2024 CYTOXAN (LYOPHILIZED) — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Sep 2024 LYOPHILIZED CYTOXAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 20 Nov 2023 CYCLOPHOSPHAMIDE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 26 Sep 2019 CYCLOPHOSPHAMIDE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.