Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021947
Company: CEPHALON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTORA FENTANYL CITRATE EQ 0.1MG BASE TABLET;BUCCAL, SUBLINGUAL Prescription None Yes No
FENTORA FENTANYL CITRATE EQ 0.2MG BASE TABLET;BUCCAL, SUBLINGUAL Prescription None Yes No
FENTORA FENTANYL CITRATE EQ 0.4MG BASE TABLET;BUCCAL, SUBLINGUAL Prescription None Yes Yes
FENTORA FENTANYL CITRATE EQ 0.6MG BASE TABLET;BUCCAL, SUBLINGUAL Prescription None Yes No
FENTORA FENTANYL CITRATE EQ 0.8MG BASE TABLET;BUCCAL, SUBLINGUAL Prescription None Yes No
FENTORA FENTANYL CITRATE EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;BUCCAL, SUBLINGUAL Discontinued None Yes No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
09/25/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021947lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021947s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021947s000FentoraTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021947s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021947Orig1s029ltr.pdf
09/07/2017 SUPPL-27 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021947Orig1s027ltr.pdf
01/12/2017 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/16/2016 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021947Orig1s024,s025ltr.pdf
12/16/2016 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021947Orig1s024,s025ltr.pdf
12/24/2014 SUPPL-22 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021947Orig1s022ltr.pdf
08/29/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/11/2017 SUPPL-19 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021947s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021947Orig1s019ltr.pdf
11/07/2013 SUPPL-17 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021947Orig1s017ltr.pdf
06/05/2012 SUPPL-15 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021947s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021947s015ltr.pdf
05/19/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/28/2011 SUPPL-13 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021947s013ltr.pdf
01/20/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021947s011ltr.pdf
12/02/2009 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021947s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021947s010ltr.pdf
07/20/2011 SUPPL-9 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021947Orig1s009ltr.pdf
02/21/2013 SUPPL-8 Efficacy-New Route Of Administration Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021947s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021947Orig1s008ltr.pdf
02/07/2008 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021947s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021947s006ltr.pdf
03/02/2007 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021947s002ltr.pdf
04/27/2007 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021947s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021947s029lbl.pdf
10/07/2019 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021947s029lbl.pdf
04/11/2017 SUPPL-19 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021947s019lbl.pdf
12/16/2016 SUPPL-25 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf
12/16/2016 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf
12/16/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf
12/16/2016 SUPPL-24 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021947s024s025lbl.pdf
02/21/2013 SUPPL-8 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021947s008lbl.pdf
06/05/2012 SUPPL-15 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021947s015lbl.pdf
12/28/2011 SUPPL-13 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s013lbl.pdf
07/20/2011 SUPPL-9 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s009lbl.pdf
07/20/2011 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s009lbl.pdf
01/20/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s011lbl.pdf
12/02/2009 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021947s010lbl.pdf
02/07/2008 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021947s006lbl.pdf
04/27/2007 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s001lbl.pdf
03/02/2007 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s002lbl.pdf
03/02/2007 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s002lbl.pdf
09/25/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021947lbl.pdf

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