Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019813
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DURAGESIC-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
DURAGESIC-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
DURAGESIC-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes Yes
DURAGESIC-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
DURAGESIC-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
DURAGESIC-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB 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
10/07/2019 SUPPL-79 Labeling-Medication Guide, Labeling-Package Insert 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-Package Insert, Labeling-Container/Carton Labels 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
10/07/2019 SUPPL-79 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019813s079lbl.pdf
10/07/2019 SUPPL-79 Labeling-Package Insert 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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019813s044lblnew.pdf
07/31/2009 SUPPL-44 Labeling-Container/Carton Labels 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

DURAGESIC-100

FILM, EXTENDED RELEASE;TRANSDERMAL; 100MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 202097 3M DRUG DELIVERY
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077051 LAVIPHARM LABS
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077154 SPECGX LLC

DURAGESIC-12

FILM, EXTENDED RELEASE;TRANSDERMAL; 12.5MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 202097 3M DRUG DELIVERY
FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES
FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077154 SPECGX LLC

DURAGESIC-25

FILM, EXTENDED RELEASE;TRANSDERMAL; 25MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 202097 3M DRUG DELIVERY
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077051 LAVIPHARM LABS
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077154 SPECGX LLC

DURAGESIC-37

FILM, EXTENDED RELEASE;TRANSDERMAL; 37.5MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES

DURAGESIC-50

FILM, EXTENDED RELEASE;TRANSDERMAL; 50MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 202097 3M DRUG DELIVERY
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077051 LAVIPHARM LABS
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077154 SPECGX LLC

DURAGESIC-75

FILM, EXTENDED RELEASE;TRANSDERMAL; 75MCG/HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAGESIC-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 019813 JANSSEN PHARMS
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 202097 3M DRUG DELIVERY
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077449 AVEVA
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077051 LAVIPHARM LABS
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076258 MYLAN TECHNOLOGIES
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 077154 SPECGX LLC

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