Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021947
Company: CEPHALON
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 | AB | Yes | No |
| FENTORA | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET;BUCCAL, SUBLINGUAL | Prescription | AB | Yes | No |
| FENTORA | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET;BUCCAL, SUBLINGUAL | Prescription | AB | Yes | Yes |
| FENTORA | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET;BUCCAL, SUBLINGUAL | Prescription | AB | Yes | No |
| FENTORA | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET;BUCCAL, SUBLINGUAL | Prescription | AB | Yes | No |
| FENTORA | FENTANYL CITRATE | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021947s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021947Orig1s043ltr.pdf | |
| 12/08/2022 | SUPPL-42 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021947Orig1s042ltr.pdf |
| 08/17/2022 | SUPPL-40 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021947Orig1s040ltr.pdf |
| 11/22/2022 | SUPPL-38 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021947s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021947Orig1s038ltr.pdf | |
| 12/03/2021 | SUPPL-37 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021947Orig1s037Correctedltr.pdf |
| 03/04/2021 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021947s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021947Orig1s034ltr.pdf | |
| 12/23/2020 | SUPPL-30 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021947Orig1s030ltr.pdf |
| 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-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 | |
| 12/24/2014 | 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 | Labeling, REMS-Proposal |
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-Container/Carton Labels, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021947s043lbl.pdf | |
| 11/22/2022 | SUPPL-38 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021947s038lbl.pdf | |
| 03/04/2021 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021947s034lbl.pdf | |
| 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-Medication Guide | 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 | |
| 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 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s009lbl.pdf | |
| 07/20/2011 | SUPPL-9 | REMS-Proposal | 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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s002lbl.pdf | |
| 03/02/2007 | SUPPL-2 | Labeling-Package Insert | 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 |
FENTORA
TABLET;BUCCAL, SUBLINGUAL; EQ 0.1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTORA | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 021947 | CEPHALON |
TABLET;BUCCAL, SUBLINGUAL; EQ 0.2MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTORA | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 021947 | CEPHALON |
TABLET;BUCCAL, SUBLINGUAL; EQ 0.4MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTORA | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 021947 | CEPHALON |
TABLET;BUCCAL, SUBLINGUAL; EQ 0.6MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTORA | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 021947 | CEPHALON |
TABLET;BUCCAL, SUBLINGUAL; EQ 0.8MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTORA | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 021947 | CEPHALON |