NDA 212501, held by Dr Reddys. Cyclophosphamide.
As of Nov 13, 2026, NDA 212501 (Cyclophosphamide), held by Dr Reddys, was first approved by FDA on Jul 30, 2020, with 3 approved supplements and 2 published complete response letters.
Cyclophosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 2020 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Jan 14, 2020 | CyclophosphamideFacility Inspections | Approved |
| Jul 18, 2019 | CyclophosphamideFacility Inspections | Approved |
| 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 |
| Mar 11, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Nov 19, 2021 | Supplement 3Manufacturing | Approved | |
| Sep 9, 2021 | Supplement 2Labeling · Standard review | Approved | |
| Jul 30, 2020 | 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
