FDA.reportPublic FDA data

Application 219271

Type
ANDA
Sponsor
HETERO LABS LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEINJECTION;SOLUTION500MG/2.5MLNoNo
003CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEINJECTION;SOLUTION2000MG/10MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDEEVER Pharma Jena GmbH571a5a63-fb66-0617-e063-6394a90a2d042026-08-04Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEOPKO Pharmaceuticals, LLCd8057d1a-e8af-42ab-9da2-b545730b26552026-05-04Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEOPKO Pharmaceuticals, LLC7d6447e3-22c9-48d9-87c0-d0b576d7ea9e2026-04-21Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDENexus Pharmaceuticals, LLCc961a1ac-6705-4756-9abc-9d84a6fcb5c82026-03-30Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratories1d3396d8-4c03-4a28-890a-d87c6c53a74e2026-03-12Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratoriesd7e97b99-83db-42d0-8521-b87fe6467a672026-02-12Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEAvenacy, LLC1de02105-9c5b-4d11-bddf-bf8450d88b782026-02-01Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEAmneal Pharmaceuticals LLC520bfe39-dfd5-4a20-9a37-80078afded0d2026-01-19Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBamboo US Bidco LCC2873b99a-830d-0a7b-e063-6394a90a4de72025-12-03Warnings, Adverse reactionsName fallback
brand name: CYCLOPHOSPHAMIDE
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEEpic Pharma, LLC988d2f71-1dc7-45b5-b2df-187e682249732025-11-17Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDECivica, Inc.8627c83f-c057-495d-9f78-8b67bda97b3e2025-10-24Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
FrindovyxCYCLOPHOSPHAMIDEAvyxa Pharma, LLC5ad8ea65-4c98-487a-9c8d-df778765ec5e2025-08-11Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBluePoint Laboratories0afd2cc7-09e6-481a-afea-9d2e3742da462025-08-07Warnings, Adverse reactionsName fallback
brand name: CYCLOPHOSPHAMIDE
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEBaxter Healthcare Company591d9955-3d9c-4cdc-a308-2f1288376b9f2025-06-24Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company97ab446f-5017-4180-ae65-0a355289b0ed2025-06-20Warnings, Adverse reactionsName fallback
brand name: CYCLOPHOSPHAMIDE
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEEugia US LLC3c1eb470-0bba-457d-94e3-b9508f0d398a2025-04-21Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONSlate Run Pharmaceuticals, LLC20bda486-cb9a-4d67-8c41-50e9fd0664342025-04-02Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEDr. Reddy's Labratories Inc.a5818647-d840-e9d7-c7b8-6541b485e44e2025-03-11Warnings, Adverse reactionsName fallback
brand name: CYCLOPHOSPHAMIDE
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDESandoz Inc.0e9e22fa-178a-42fc-9f82-c303db3b245a2025-03-05Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDESagent Pharmaceuticals329b5a3a-c7b9-4b11-abf0-009719cdfb792025-01-22Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE