Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022249
Company: CEPHALON
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 | 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 |
| 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 |