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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019813
Company: JANSSEN PHARMS

Medication Guide

Other Important Information from FDA

REMS

Products on NDA 19813

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DURAGESIC-100	FENTANYL	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	Yes	No
DURAGESIC-12	FENTANYL	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	Yes	No
DURAGESIC-25	FENTANYL	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	Yes	No
DURAGESIC-37	FENTANYL	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	Yes	No
DURAGESIC-50	FENTANYL	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	Yes	No
DURAGESIC-75	FENTANYL	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	Yes	No

Labels for NDA 019813

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

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