Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021947
Company: CEPHALON
Company: CEPHALON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTORA | FENTANYL CITRATE | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | Yes | No |
| FENTORA | FENTANYL CITRATE | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | Yes | No |
| FENTORA | FENTANYL CITRATE | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | Yes | No |
| FENTORA | FENTANYL CITRATE | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | Yes | No |
| FENTORA | FENTANYL CITRATE | EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | Yes | No |
| FENTORA | FENTANYL CITRATE | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021947s046lbl.pdf | |
| 12/15/2023 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021947s043lbl.pdf | |
| 11/22/2022 | SUPPL-38 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021947s038lbl.pdf | |
| 03/04/2021 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021947s034lbl.pdf | |
| 10/07/2019 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021947s029lbl.pdf | |
| 10/07/2019 | SUPPL-29 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021947s029lbl.pdf | |
| 04/11/2017 | SUPPL-19 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021947s019lbl.pdf | |
| 12/16/2016 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf | |
| 12/16/2016 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf | |
| 12/16/2016 | SUPPL-24 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf | |
| 12/16/2016 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf | |
| 02/21/2013 | SUPPL-8 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021947s008lbl.pdf | |
| 06/05/2012 | SUPPL-15 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021947s015lbl.pdf | |
| 12/28/2011 | SUPPL-13 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s013lbl.pdf | |
| 07/20/2011 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s009lbl.pdf | |
| 07/20/2011 | SUPPL-9 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s009lbl.pdf | |
| 01/20/2011 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s011lbl.pdf | |
| 12/02/2009 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021947s010lbl.pdf | |
| 02/07/2008 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021947s006lbl.pdf | |
| 04/27/2007 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s001lbl.pdf | |
| 03/02/2007 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s002lbl.pdf | |
| 03/02/2007 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s002lbl.pdf | |
| 09/25/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021947lbl.pdf |