Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022249
Company: CEPHALON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TREANDA BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER;IV (INFUSION) Prescription None Yes Yes
TREANDA BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER;IV (INFUSION) Prescription None 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
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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022249s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English