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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022249
Company: CEPHALON

Summary Review

Products on NDA 022249

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TREANDA	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	AP	Yes	Yes
TREANDA	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	AP	Yes	Yes
TREANDA	BENDAMUSTINE HYDROCHLORIDE	45MG/0.5ML (90MG/ML)	SOLUTION;IV (INFUSION)	Discontinued	None	Yes	No
TREANDA	BENDAMUSTINE HYDROCHLORIDE	180MG/2ML (90MG/ML)	SOLUTION;IV (INFUSION)	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022249

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/20/2008	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022249lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022249s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/treanda_022249_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/22249s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2022	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022249s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022249Orig1s026ltr.pdf
06/10/2021	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022249s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022249Orig1s025ltr.pdf
11/21/2019	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022249s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022249Orig1s024ltr.pdf
12/15/2017	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022249s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022249Orig1s023ltr.pdf
10/18/2016	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022249s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022249Orig1s022ltr.pdf
09/02/2015	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022249Orig1s021.pdf
11/05/2015	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s020ltr.pdf
03/10/2015	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022249Orig1s019.pdf
07/08/2015	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/27/2014	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
09/13/2013	SUPPL-15	Manufacturing (CMC)	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022249Orig1s015.pdf
08/28/2013	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022249Orig1s014ltr.pdf
06/26/2012	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022249s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022249s012ltr.pdf
12/21/2010	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022249s006ltr.pdf
02/26/2010	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022249s005ltr.pdf
04/22/2009	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022249s002,022303s000ltr.pdf
05/01/2009	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022249s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022249Orig1s001.pdf

Labels for NDA 022249

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2022	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022249s026lbl.pdf
06/10/2021	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022249s025lbl.pdf
11/21/2019	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022249s024lbl.pdf
12/15/2017	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022249s023lbl.pdf
10/18/2016	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022249s022lbl.pdf
11/05/2015	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249s020lbl.pdf
09/02/2015	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249s021lbl.pdf
03/10/2015	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249Orig1s019lbl.pdf
03/10/2015	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249Orig1s019lbl.pdf
09/13/2013	SUPPL-15	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s015lbl.pdf
08/28/2013	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s014lbl.pdf
06/26/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022249s012lbl.pdf
12/21/2010	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s006lbl.pdf
02/26/2010	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s005lbl.pdf
05/01/2009	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s001lbl.pdf
05/01/2009	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s001lbl.pdf
04/22/2009	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s002lbl.pdf
03/20/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022249lbl.pdf

Therapeutic Equivalents for NDA 022249

TREANDA

POWDER;IV (INFUSION); 100MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205574	ACCORD HLTHCARE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	204230	APOTEX
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205447	BRECKENRIDGE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205376	DR REDDYS
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	214739	EUGIA PHARMA
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	211001	KINDOS
TREANDA	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	Yes	AP	022249	CEPHALON

POWDER;IV (INFUSION); 25MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205574	ACCORD HLTHCARE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	204230	APOTEX
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205447	BRECKENRIDGE
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205376	DR REDDYS
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	214739	EUGIA PHARMA
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	211001	KINDOS
TREANDA	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	Yes	AP	022249	CEPHALON

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