FDA.reportPublic FDA data

Application 088372

Type
ANDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEINJECTABLE;INJECTION200MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088372-001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE200MG/VIALINJECTABLE / INJECTION1986-07-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A088372-001CYCLOPHOSPHAMIDE200MG/VIALINJECTABLE / INJECTION1986-07-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088372-001CYCLOPHOSPHAMIDE200MG/VIALINJECTABLE / INJECTION1986-07-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088372-001CYCLOPHOSPHAMIDE200MG/VIALINJECTABLE / INJECTION1986-07-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A088372-001CYCLOPHOSPHAMIDE200MG/VIALINJECTABLE / INJECTION1986-07-03a50c72e98297…

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 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDENexus Pharmaceuticals, LLCc961a1ac-6705-4756-9abc-9d84a6fcb5c82026-09-03Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
FrindovyxCYCLOPHOSPHAMIDEAVYXA Pharma, LLC5ad8ea65-4c98-487a-9c8d-df778765ec5e2026-08-26Warnings, Adverse reactionsName fallback
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
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
CyclophosphamideCYCLOPHOSPHAMIDECipla USA Inc.0e1cb955-99c8-4fe5-89d1-399c8e52174e2025-01-10Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONHainan Poly Pharm. Co., Ltd.6fde2705-a2d8-4d48-9618-b9d99d0513732025-01-03Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDESandoz Inccf2f4b95-0327-499a-a5a3-51b1bdef68c52024-12-30Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
generic name: CYCLOPHOSPHAMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.