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Drugs@FDA: FDA-Approved Drugs

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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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249Orig1s019lbl.pdf
03/10/2015 SUPPL-19 Labeling-Package Insert 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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s001lbl.pdf
05/01/2009 SUPPL-1 Labeling-Container/Carton Labels 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
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