Application 012142

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYTOXANCYCLOPHOSPHAMIDEINJECTABLE;INJECTION100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CYTOXANCYCLOPHOSPHAMIDEINJECTABLE;INJECTION200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDEINJECTABLE;INJECTION500MG/VIALYesNo
004CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDEINJECTABLE;INJECTION1GM/VIALYesNo
005CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDEINJECTABLE;INJECTION2GM/VIALYesNo
006LYOPHILIZED CYTOXANCYCLOPHOSPHAMIDEINJECTABLE;INJECTION100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
007LYOPHILIZED CYTOXANCYCLOPHOSPHAMIDEINJECTABLE;INJECTION200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
008CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDEINJECTABLE;INJECTION500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
009CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDEINJECTABLE;INJECTION2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
010CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDEINJECTABLE;INJECTION1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012142-001CYTOXANCYCLOPHOSPHAMIDE100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982
N012142-002CYTOXANCYCLOPHOSPHAMIDE200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982
N012142-003CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982
N012142-004CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30
N012142-005CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30
N012142-006LYOPHILIZED CYTOXANCYCLOPHOSPHAMIDE100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-05
N012142-007LYOPHILIZED CYTOXANCYCLOPHOSPHAMIDE200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10
N012142-008CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-01-04
N012142-009CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10
N012142-010CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-09-24

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 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N012142-001CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-002CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-003CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-004CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-005CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-006LYOPHILIZED CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-05caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-007LYOPHILIZED CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-008CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-01-04caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-009CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-010CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N012142-001CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-002CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-003CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-004CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-005CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-006LYOPHILIZED CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-007LYOPHILIZED CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-008CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-01-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-009CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-010CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-001CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-002CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-003CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-004CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-005CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-006LYOPHILIZED CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-007LYOPHILIZED CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-008CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-01-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-009CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-010CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N012142-001CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-002CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-003CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-004CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-005CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-006LYOPHILIZED CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-007LYOPHILIZED CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-008CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-01-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-009CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-010CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-09-246a471c1ec25d…

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
CyclophosphamideCYCLOPHOSPHAMIDEEVER Pharma Jena GmbH571a5a63-fb66-0617-e063-6394a90a2d042026-08-12Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEOPKO Pharmaceuticals, LLCd8057d1a-e8af-42ab-9da2-b545730b26552026-05-04Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEOPKO Pharmaceuticals, LLC7d6447e3-22c9-48d9-87c0-d0b576d7ea9e2026-04-21Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDENexus Pharmaceuticals, LLCc961a1ac-6705-4756-9abc-9d84a6fcb5c82026-03-30Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratories1d3396d8-4c03-4a28-890a-d87c6c53a74e2026-03-12Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratoriesd7e97b99-83db-42d0-8521-b87fe6467a672026-02-12Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEAvenacy, LLC1de02105-9c5b-4d11-bddf-bf8450d88b782026-02-01Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEAmneal Pharmaceuticals LLC520bfe39-dfd5-4a20-9a37-80078afded0d2026-01-19Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBamboo US Bidco LCC2873b99a-830d-0a7b-e063-6394a90a4de72025-12-03Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEEpic Pharma, LLC988d2f71-1dc7-45b5-b2df-187e682249732025-11-17Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDECivica, Inc.8627c83f-c057-495d-9f78-8b67bda97b3e2025-10-24Warnings, Adverse reactionsName fallback
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
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEBaxter Healthcare Company591d9955-3d9c-4cdc-a308-2f1288376b9f2025-06-24Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company97ab446f-5017-4180-ae65-0a355289b0ed2025-06-20Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEEugia US LLC3c1eb470-0bba-457d-94e3-b9508f0d398a2025-04-21Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEDr. Reddy's Labratories Inc.a5818647-d840-e9d7-c7b8-6541b485e44e2025-03-11Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDESandoz Inc.0e9e22fa-178a-42fc-9f82-c303db3b245a2025-03-05Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDESagent Pharmaceuticals329b5a3a-c7b9-4b11-abf0-009719cdfb792025-01-22Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDECipla USA Inc.0e1cb955-99c8-4fe5-89d1-399c8e52174e2025-01-10Warnings, Adverse reactionsName fallback
generic name: CYCLOPHOSPHAMIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10019-988CYCLOPHOSPHAMIDECyclophosphamideBaxter Healthcare CorporationNDACurrent
10019-988CYCLOPHOSPHAMIDECyclophosphamideBaxter Healthcare CorporaNDACurrent
10019-989CYCLOPHOSPHAMIDECyclophosphamideBaxter Healthcare CorporationNDACurrent
10019-989CYCLOPHOSPHAMIDECyclophosphamideBaxter Healthcare CorporaNDACurrent
10019-990CYCLOPHOSPHAMIDECyclophosphamideBaxter Healthcare CorporationNDACurrent
10019-990CYCLOPHOSPHAMIDECyclophosphamideBaxter Healthcare CorporaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79553SUPPL 2024-09-06
79549SUPPL 2024-09-06
307SUPPL2013-05-10
10794SUPPL2013-05-09
306SUPPL2012-04-04
33075SUPPL2012-04-02
11990SUPPL2003-11-25