FDA.reportPublic FDA data

CYCLOPHOSPHAMIDE - Food and Drug Administration

Set ID
fbc3d08d-10bd-4e59-b59d-d530aede5bad
Type
Indexing - product concept
Effective date
2022-03-08
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE CAPSULES safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE CAPSULES. CYCLOPHOSPHAMIDE capsules, for oral use Initial U.S. Approval: 1959Product nameOPKO Pharmaceuticals, LLC2026-09-28
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE CAPSULES safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE CAPSULES. CYCLOPHOSPHAMIDE capsules, for oral use Initial U.S. Approval: 1959Product nameOPKO Pharmaceuticals, LLC2026-09-28
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameNexus Pharmaceuticals, LLC2026-09-03
These highlights do not include all the information needed to use FRINDOVYX safely and effectively. See full prescribing information for FRINDOVYX. FRINDOVYX TM (cyclophosphamide) injection, for intravenous use Initial U.S. Approval: 1959Product nameAVYXA Pharma, LLC | Avyxa Holdings, LLC.2026-08-26
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE CAPSULES safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE CAPSULES. CYCLOPHOSPHAMIDE capsules, for oral use Initial U.S. Approval: 1959Product nameOPKO Pharmaceuticals, LLC2026-05-04
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameNorthStar RxLLC | Amneal Oncology Private Limited2026-04-24
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE CAPSULES safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE CAPSULES. CYCLOPHOSPHAMIDE capsules, for oral use Initial U.S. Approval: 1959Product nameOPKO Pharmaceuticals, LLC2026-04-21
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameNexus Pharmaceuticals, LLC2026-03-30
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBluePoint Laboratories | Epic Pharma LLC2026-03-12
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameNexus Pharmaceuticals, LLC2026-03-06
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBluePoint Laboratories | Baxter Healthcare Corporation | Baxter Oncology GmbH2026-02-12
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameAvenacy, LLC2026-02-01
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameAmneal Pharmaceuticals LLC2026-01-19
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBamboo US Bidco LCC2025-12-03
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameEpic Pharma, LLC2025-11-17
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameCivica, Inc. | Baxter Healthcare Corporation2025-10-24
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameCivica, Inc. | Baxter Healthcare Corporation2025-10-24
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameCivica, Inc.2025-10-24
These highlights do not include all the information needed to use FRINDOVYX safely and effectively. See full prescribing information for FRINDOVYX. FRINDOVYX TM (cyclophosphamide) injection, for intravenous use Initial U.S. Approval: 1959Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC.2025-08-11
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameBluePoint Laboratories | Ingenus Pharmaceuticals GmbH2025-08-07
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Corporation2025-06-24
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Company | Baxter Healthcare Corporation2025-06-24
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION . CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Company2025-06-20
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION . CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Corporation2025-06-20
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameEugia US LLC | EUGIA Pharma Specialities Limited2025-04-21
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameSlate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd.2025-04-02
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameDr. Reddy's Labratories Inc.2025-03-11
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE . CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameSandoz Inc.2025-03-05
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION . CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Corporation2025-01-30
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION . CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Corporation2025-01-30
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameCivica, Inc.2025-01-30
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameCivica, Inc.2025-01-30
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameSagent Pharmaceuticals2025-01-22
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE CAPSULES safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE CAPSULES CYCLOPHOSPHAMIDE capsules, for oral use Initial U.S. Approval:1959Product nameCipla USA Inc. | CIPLA LIMITED GOA2025-01-10
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameHainan Poly Pharm. Co., Ltd.2025-01-03
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameSandoz Inc2024-12-30
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameXGen Pharmaceuticals DJB, Inc.2024-12-20
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE CAPSULES safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE CAPSULES. CYCLOPHOSPHAMIDE capsules, for oral use Initial U.S. Approval: 1959Product nameAlembic Pharmaceuticals Limited2024-12-16
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE CAPSULES safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE CAPSULES. CYCLOPHOSPHAMIDE capsules, for oral use Initial U.S. Approval: 1959Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2024-12-10
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE . CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameNorthStar Rx LLC2024-11-20
These highlights do not include all the information needed to use Cyclophosphamide Capsules safely and effectively. See full prescribing information for Cyclophosphamide Capsules. Cyclophosphamide capsules, for oral use Initial U.S. Approval: 1959Product nameHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.2024-11-19
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE . CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameFresenius Kabi USA, LLC | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)2024-10-09
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC. | Dr.Reddys Laboratories Limited2024-07-26
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Company2024-04-10
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Company2024-04-10
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION . CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameLong Grove Pharmaceuticals, LLC2023-11-10
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE FOR INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE FOR INJECTION. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameNorthStar RxLLC | Amneal Oncology Private Limited2023-10-06
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE INJECTION, for intravenous use Initial U.S. Approval: 1959Product nameNevakar Injectables Inc.2023-07-11
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959Product nameBluePoint Laboratories | Ingenus Pharmaceuticals GmbH2023-05-05
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE TABLETS safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE TABLETS . CYCLOPHOSPHAMIDE tablets, for oral use Initial U.S. Approval: 1959Product nameBaxter Healthcare Company | Baxter Deutschland GmbH2020-08-07
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE TABLETS safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE TABLETS. CYCLOPHOSPHAMIDE tablets, for oral use Initial U.S. Approval: 1959Product nameBaxter Healthcare Corporation | Baxter Deutschland GmbH2020-08-07
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE TABLETS safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE TABLETS. CYCLOPHOSPHAMIDE tablets, for oral use Initial U.S. Approval: 1959Product nameBaxter Healthcare Corporation | Baxter Deutschland GmbH2020-08-07
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE . CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Company2017-03-15
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE . CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Corporation2017-03-15
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE . CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Corporation2017-03-15
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Corporation2017-03-15
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Corporation2017-03-15
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959Product nameBaxter Healthcare Company2017-03-15
CYCLOPHOSPHAMIDE Tablets USP, 25 mg and 50 mgProduct namePhysicians Total Care, Inc.2012-01-23