FDA.reportPublic FDA data

Application 022303

Type
NDA
Sponsor
CEPHALON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TREANDABENDAMUSTINE HYDROCHLORIDEINJECTABLE; INJECTION100MGYesNo

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 1 ยท 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDEAvyxa Pharma, LLCf359e7c6-d104-457d-a7fe-597c744403532026-05-14Warnings, Adverse reactionsName fallback
generic name: BENDAMUSTINE HYDROCHLORIDE
Bendamustine HydrochlorideBENDAMUSTINE HYDROCHLORIDEApotex Corp085dd54c-4212-d879-afef-ee52732a48c02025-09-16Warnings, Adverse reactionsName fallback
generic name: BENDAMUSTINE HYDROCHLORIDE
VIVIMUSTABENDAMUSTINE HYDROCHLORIDEAzurity Pharmaceuticals, Inc.4df6548f-c4ad-4eb2-a54f-19766a3d90ca2025-04-03Warnings, Adverse reactionsName fallback
generic name: BENDAMUSTINE HYDROCHLORIDE
BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDEBaxter Healthcare Corporation766b73e2-49bb-47f9-bbb1-44cfa1a3197e2025-02-10Warnings, Adverse reactionsName fallback
generic name: BENDAMUSTINE HYDROCHLORIDE
BELRAPZOBENDAMUSTINE HYDROCHLORIDEEagle Pharmaceuticals, Inc9759a4ae-82ca-40cf-9c02-e1cadb21cbdc2024-09-23Warnings, Adverse reactionsName fallback
generic name: BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochlorideBENDAMUSTINE HYDROCHLORIDEAccord Healthcare, Inc.33867f0f-f317-1fd0-e054-00144ff8d46c2024-07-18Warnings, Adverse reactionsName fallback
generic name: BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochlorideBENDAMUSTINE HYDROCHLORIDEBluePoint Laboratories0df025d2-c093-427a-b599-f605e71fe8352024-03-29Warnings, Adverse reactionsName fallback
generic name: BENDAMUSTINE HYDROCHLORIDE
VIVIMUSTABENDAMUSTINE HYDROCHLORIDESlayback Pharma LLCcbcc6eb7-aa62-4599-af49-05203fedb4bb2024-02-27Warnings, Adverse reactionsName fallback
generic name: BENDAMUSTINE HYDROCHLORIDE
BendekaBENDAMUSTINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.ace9a43b-f9bd-4896-abfe-0ef4fec67ddf2024-01-19Warnings, Adverse reactionsName fallback
generic name: BENDAMUSTINE HYDROCHLORIDE
BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDEEugia US LLCdbe34bc1-06b2-493f-8859-e8b143357aa82023-07-05Warnings, Adverse reactionsName fallback
generic name: BENDAMUSTINE HYDROCHLORIDE
TREANDABENDAMUSTINE HYDROCHLORIDECephalon, LLC39d53698-57fa-7c99-fc5b-f52a556848262022-10-27Warnings, Adverse reactionsName fallback
brand name: TREANDA
generic name: BENDAMUSTINE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24277ORIG2009-08-27
21987ORIG2009-08-27
29550ORIG2008-11-07
38531ORIG2008-11-03