Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020747
Company: CEPHALON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTIQ FENTANYL CITRATE EQ 0.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription AB Yes No
ACTIQ FENTANYL CITRATE EQ 0.4MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription AB Yes Yes
ACTIQ FENTANYL CITRATE EQ 0.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription AB Yes No
ACTIQ FENTANYL CITRATE EQ 0.8MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription AB Yes No
ACTIQ FENTANYL CITRATE EQ 1.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription AB Yes No
ACTIQ FENTANYL CITRATE EQ 1.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL 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
11/04/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20747lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20747ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20747_Actiq.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2017 SUPPL-47 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020747Orig1s047ltr.pdf
12/16/2016 SUPPL-44 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020747Orig1s043,s044ltr.pdf
12/16/2016 SUPPL-43 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020747Orig1s043,s044ltr.pdf
12/24/2014 SUPPL-41 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020747Orig1s041ltr.pdf
04/30/2014 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

04/22/2013 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/07/2013 SUPPL-37 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020747Orig1s037ltr.pdf
06/05/2012 SUPPL-34 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020747s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020747s034ltr.pdf
12/28/2011 SUPPL-33 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020747s033ltr.pdf
11/09/2009 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020747s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020747s030ltr.pdf
07/20/2011 SUPPL-29 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020747Orig1s029ltr.pdf
02/07/2007 SUPPL-27 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020747s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020747s027ltr.pdf
09/06/2006 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020747s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020747s023_ltr.pdf
09/09/2005 SUPPL-19 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020747s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020747s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020747_S019_ACTIQ.pdf
01/19/2005 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020747s018ltr.pdf
09/24/2004 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20747s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20747s017ltr.pdf
06/10/2002 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747s011ltr.pdf
03/12/2002 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747s10ltr.pdf
01/29/2003 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747slr009ltr.pdf
02/19/2003 SUPPL-8 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20747scm008ltr.pdf
04/09/2001 SUPPL-6 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20747S6ltr.pdf
08/25/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1999 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020747Orig1s003.pdf
03/26/1999 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2016 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf
12/16/2016 SUPPL-44 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf
12/16/2016 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf
12/16/2016 SUPPL-43 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf
06/05/2012 SUPPL-34 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020747s034lbl.pdf
12/28/2011 SUPPL-33 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s033lbl.pdf
07/20/2011 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf
07/20/2011 SUPPL-29 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf
11/09/2009 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020747s030lbl.pdf
02/07/2007 SUPPL-27 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020747s027lbl.pdf
09/06/2006 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020747s023lbl.pdf
09/09/2005 SUPPL-19 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020747s019lbl.pdf
09/24/2004 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20747s017lbl.pdf
11/04/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20747lbl.pdf

ACTIQ

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 0.2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 0.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 0.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 MALLINCKRODT
FENTANYL CITRATE FENTANYL CITRATE EQ 0.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 077312 PAR PHARM

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 0.4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 0.4MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 0.4MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 MALLINCKRODT
FENTANYL CITRATE FENTANYL CITRATE EQ 0.4MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 077312 PAR PHARM

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 0.6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 0.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 0.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 MALLINCKRODT
FENTANYL CITRATE FENTANYL CITRATE EQ 0.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 077312 PAR PHARM

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 0.8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 0.8MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 0.8MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 MALLINCKRODT
FENTANYL CITRATE FENTANYL CITRATE EQ 0.8MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 077312 PAR PHARM

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 1.2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 1.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 1.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 MALLINCKRODT
FENTANYL CITRATE FENTANYL CITRATE EQ 1.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 077312 PAR PHARM

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 1.6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 1.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 1.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 MALLINCKRODT
FENTANYL CITRATE FENTANYL CITRATE EQ 1.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 077312 PAR PHARM

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