NDA 210735, held by Eugia Pharma Speclts. Cyclophosphamide.
As of Nov 13, 2026, NDA 210735 (Cyclophosphamide), held by Eugia Pharma Speclts, was first approved by FDA on Aug 25, 2021, with 1 approved supplement and 3 published complete response letters.
Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma multiple myeloma leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) mycosis fungoides (advanced disease) neuroblastoma (disseminated disease) ade…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 2021 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 1, 2019 | CyclophosphamideFacility Inspections | Approved |
| Jan 15, 2019 | CyclophosphamideProduct Quality, Facility Inspections | Approved |
| Apr 26, 2018 | CyclophosphamideNonclinical And Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyclophosphamide500MG/2.5ML (200MG/ML) · solution;intravenous | Cyclophosphamide | RxReference drug |
| Cyclophosphamide1GM/5ML (200MG/ML) · solution;intravenous | Cyclophosphamide | RxReference drug |
| Cyclophosphamide2GM/10ML (200MG/ML) · solution;intravenous | Cyclophosphamide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Aug 25, 2021 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
