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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 Discontinued None Yes No
DURAGESIC-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
DURAGESIC-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
DURAGESIC-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
DURAGESIC-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
DURAGESIC-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019813s069lbl.pdf
12/16/2016 SUPPL-69 Labeling-Package Insert 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
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