Application 040745

Type
ANDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEINJECTABLE;INJECTION500MG/VIALNoYes
002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEINJECTABLE;INJECTION1GM/VIALNoYes
003CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEINJECTABLE;INJECTION2GM/VIALNoYes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040745-001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21
A040745-002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21
A040745-003CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040745-001AP
A040745-002AP
A040745-003AP

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-211e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040745-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A040745-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A040745-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040745-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040745-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040745-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040745-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040745-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040745-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040745-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040745-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040745-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040745-001AP11e350fbaab3a…

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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratoriesd7e97b99-83db-42d0-8521-b87fe6467a672026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
ndc (product): 68001-442
ndc (product): 68001-444
ndc (product): 68001-443
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBamboo US Bidco LCC2873b99a-830d-0a7b-e063-6394a90a4de72025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
CyclophosphamideCYCLOPHOSPHAMIDECivica, Inc.8627c83f-c057-495d-9f78-8b67bda97b3e2025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
ndc (product): 72572-085
ndc (product): 72572-087
ndc (product): 72572-083
CyclophosphamideCYCLOPHOSPHAMIDEBaxter Healthcare Company591d9955-3d9c-4cdc-a308-2f1288376b9f2025-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
ndc (product): 10019-955
ndc (product): 10019-957
ndc (product): 10019-956
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company97ab446f-5017-4180-ae65-0a355289b0ed2025-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
ndc (product): 10019-938
ndc (product): 10019-939
ndc (product): 10019-942
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Companycef038cc-efab-46d9-99c2-95bb11d6c9bc2017-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
ndc (product): 10019-944
ndc (product): 10019-945
ndc (product): 10019-943
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe2017-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
ndc (product): 10019-937
ndc (product): 10019-936
ndc (product): 10019-935

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10019-935CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-935CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-935CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-935CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-936CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-936CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-936CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-936CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-937CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-937CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-937CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-937CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-938CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-938CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-938CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-938CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-939CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-939CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-939CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-939CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-942CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-942CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-942CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-942CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-943CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-943CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-943CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-943CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-944CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-944CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-944CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-944CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-945CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-945CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-945CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-945CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-955CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-955CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-955CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-955CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-956CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-956CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-956CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-956CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-957CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-957CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-957CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-957CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
68001-442CyclophosphamidecyclophosphamideBluePoint LaboratoriesANDACurrent
68001-443CyclophosphamidecyclophosphamideBluePoint LaboratoriesANDACurrent
68001-444CyclophosphamidecyclophosphamideBluePoint LaboratoriesANDACurrent
72572-083CyclophosphamidecyclophosphamideCivica, Inc.ANDACurrent
72572-085CyclophosphamidecyclophosphamideCivica, Inc.ANDACurrent
72572-087CyclophosphamidecyclophosphamideCivica, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17786SUPPL2014-10-27
42636ORIG2012-03-27