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 | TROCHE/LOZENGE;TRANSMUCOSAL | Prescription | None | Yes | No |
| ACTIQ | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Prescription | None | Yes | Yes |
| ACTIQ | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Prescription | None | Yes | No |
| ACTIQ | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Prescription | None | Yes | No |
| ACTIQ | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Prescription | None | Yes | No |
| ACTIQ | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 11/04/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20747lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20747ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20747_Actiq.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020747s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020747Orig1s062ltr.pdf | |
| 12/08/2022 | SUPPL-61 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020747Orig1s061ltr.pdf |
| 08/17/2022 | SUPPL-58 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020747Orig1s058ltr.pdf |
| 11/22/2022 | SUPPL-56 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020747Orig1s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020747Orig1s056ltr.pdf | |
| 12/03/2021 | SUPPL-55 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020747Orig1s055Correctedltr.pdf |
| 03/04/2021 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020747s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020747Orig1s053ltr.pdf | |
| 12/23/2020 | SUPPL-50 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020747Orig1s050ltr.pdf |
| 10/07/2019 | SUPPL-49 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020747s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020747Orig1s049ltr.pdf | |
| 09/07/2017 | SUPPL-47 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020747Orig1s047ltr.pdf |
| 12/16/2016 | SUPPL-44 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020747Orig1s043,s044ltr.pdf | |
| 12/16/2016 | SUPPL-43 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020747Orig1s043,s044ltr.pdf | |
| 12/24/2014 | SUPPL-41 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020747Orig1s041ltr.pdf |
| 04/30/2014 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/2013 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/2013 | SUPPL-37 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020747Orig1s037ltr.pdf |
| 06/05/2012 | SUPPL-34 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020747s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020747s034ltr.pdf | |
| 12/28/2011 | SUPPL-33 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020747s033ltr.pdf | |
| 11/09/2009 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020747s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020747s030ltr.pdf | |
| 07/20/2011 | SUPPL-29 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020747Orig1s029ltr.pdf | |
| 02/07/2007 | SUPPL-27 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020747s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020747s027ltr.pdf | |
| 09/06/2006 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020747s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020747s023_ltr.pdf | |
| 09/09/2005 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020747s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020747s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020747_S019_ACTIQ.pdf | |
| 01/19/2005 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020747s018ltr.pdf |
| 09/24/2004 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20747s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20747s017ltr.pdf | |
| 06/10/2002 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747s011ltr.pdf |
| 03/12/2002 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747s10ltr.pdf |
| 01/29/2003 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747slr009ltr.pdf |
| 02/19/2003 | SUPPL-8 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20747scm008ltr.pdf |
| 04/09/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20747S6ltr.pdf |
| 08/25/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1999 | SUPPL-3 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020747Orig1s003.pdf |
| 03/26/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.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-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 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf | |
| 07/20/2011 | SUPPL-29 | REMS-Proposal | 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 |