Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020747
Company: CEPHALON
Company: CEPHALON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTIQ | FENTANYL CITRATE | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | Yes | No |
| ACTIQ | FENTANYL CITRATE | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | Yes | No |
| ACTIQ | FENTANYL CITRATE | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | Yes | No |
| ACTIQ | FENTANYL CITRATE | EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | Yes | No |
| ACTIQ | FENTANYL CITRATE | EQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | Yes | No |
| ACTIQ | FENTANYL CITRATE | EQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020747s065lbl.pdf | |
| 12/15/2023 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020747s062lbl.pdf | |
| 11/22/2022 | SUPPL-56 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020747Orig1s056lbl.pdf | |
| 03/04/2021 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020747s053lbl.pdf | |
| 10/07/2019 | SUPPL-49 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020747s049lbl.pdf | |
| 10/07/2019 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020747s049lbl.pdf | |
| 12/16/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf | |
| 12/16/2016 | SUPPL-44 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf | |
| 12/16/2016 | SUPPL-43 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf | |
| 12/16/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf | |
| 06/05/2012 | SUPPL-34 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020747s034lbl.pdf | |
| 12/28/2011 | SUPPL-33 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s033lbl.pdf | |
| 07/20/2011 | SUPPL-29 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf | |
| 07/20/2011 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf | |
| 11/09/2009 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020747s030lbl.pdf | |
| 02/07/2007 | SUPPL-27 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020747s027lbl.pdf | |
| 09/06/2006 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020747s023lbl.pdf | |
| 09/09/2005 | SUPPL-19 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020747s019lbl.pdf | |
| 09/24/2004 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20747s017lbl.pdf | |
| 11/04/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20747lbl.pdf |