Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019813
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DURAGESIC-100 | FENTANYL | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |
| DURAGESIC-12 | FENTANYL | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |
| DURAGESIC-25 | FENTANYL | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |
| DURAGESIC-37 | FENTANYL | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |
| DURAGESIC-50 | FENTANYL | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |
| DURAGESIC-75 | FENTANYL | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/07/1990 | ORIG-1 | Approval | Type 2 - New Active Ingredient and Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019813_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-81 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019813Orig1s081ltr.pdf | |
| 10/07/2019 | SUPPL-79 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019813s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019813Orig1s079ltr.pdf | |
| 09/18/2018 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019813Orig1s075s076Orig1s000ltr.pdf | |
| 09/18/2018 | SUPPL-75 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019813Orig1s075s076Orig1s000ltr.pdf | |
| 05/26/2017 | SUPPL-74 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019813Orig1s074ltr.pdf |
| 01/24/2018 | SUPPL-73 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf | ||
| 01/24/2018 | SUPPL-72 | Efficacy-Manufacturing Change With Clinical Data |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf | |
| 09/30/2016 | SUPPL-71 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019813Orig1s071ltr.pdf |
| 02/02/2017 | SUPPL-70 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019813Orig1s070ltr.pdf |
| 12/16/2016 | SUPPL-69 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019813s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019813Orig1s069ltr.pdf | |
| 02/10/2017 | SUPPL-68 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019813Orig1s068ltr.pdf |
| 04/20/2016 | SUPPL-67 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019813Orig1s067ltr.pdf |
| 06/26/2015 | SUPPL-66 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019813Orig1s066ltr.pdf |
| 08/19/2014 | SUPPL-65 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019813Orig1s065ltr.pdf |
| 06/08/2014 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/2014 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019813s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019813Orig1s063ltr.pdf | |
| 09/23/2013 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019813s060lblcorrection.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019813Orig1s060ltr.pdf | |
| 07/26/2013 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/2013 | SUPPL-56 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019813Orig1s056ltr.pdf |
| 12/19/2012 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-52 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019813s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019813Orig1s052ltr.pdf | |
| 07/09/2012 | SUPPL-51 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019813Orig1s051ltr.pdf |
| 07/31/2009 | SUPPL-44 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019813s044lblnew.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/019813Orig1s044.pdf | |
| 02/04/2005 | SUPPL-39 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19813s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19813s039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019813_S039_DURAGESIC.pdf | |
| 05/20/2003 | SUPPL-36 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19813se1-036_duragesic_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19813se1-036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019813_S036_DURAGESIC.pdf | |
| 02/07/2008 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019813s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019813s033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019813Orig1s033.pdf | |
| 04/09/2001 | SUPPL-30 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19813S30ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S030_DURAGESIC.pdf |
| 11/09/2000 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/2000 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/2000 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/2000 | SUPPL-26 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S026_DURAGESIC.pdf |
| 11/01/2000 | SUPPL-25 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S025_DURAGESIC.pdf |
| 12/02/1999 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2001 | SUPPL-23 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19813S30ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019813_S023_DURAGESIC.pdf |
| 12/07/1999 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/17/1997 | SUPPL-21 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S021_Duragesic.pdf |
| 07/17/1997 | SUPPL-20 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S020_Duragesic.pdf |
| 07/17/1997 | SUPPL-19 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S019_Duragesic.pdf |
| 07/17/1997 | SUPPL-18 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019813_S018_Duragesic.pdf |
| 11/07/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/29/1994 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/19/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1994 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/25/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/11/1993 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/28/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/12/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1991 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf | |
| 10/07/2019 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019813s079lbl.pdf | |
| 10/07/2019 | SUPPL-79 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019813s079lbl.pdf | |
| 09/18/2018 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf | |
| 09/18/2018 | SUPPL-75 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf | |
| 01/24/2018 | SUPPL-73 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf | |
| 01/24/2018 | SUPPL-72 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf | |
| 12/16/2016 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019813s069lbl.pdf | |
| 12/16/2016 | SUPPL-69 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019813s069lbl.pdf | |
| 04/16/2014 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019813s063lbl.pdf | |
| 09/23/2013 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019813s060lblcorrection.pdf | |
| 07/09/2012 | SUPPL-52 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019813s052lbl.pdf | |
| 07/31/2009 | SUPPL-44 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019813s044lblnew.pdf | |
| 07/31/2009 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019813s044lblnew.pdf | |
| 02/07/2008 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019813s033lbl.pdf | |
| 02/04/2005 | SUPPL-39 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19813s039lbl.pdf | |
| 05/20/2003 | SUPPL-36 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19813se1-036_duragesic_lbl.pdf |