Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022187
Company: JANSSEN R AND D
Company: JANSSEN R AND D
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INTELENCE | ETRAVIRINE | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| INTELENCE | ETRAVIRINE | 200MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| INTELENCE | ETRAVIRINE | 25MG | TABLET;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 01/18/2008 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022187lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022187s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022187TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022187s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/10/2019 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022187s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022187Orig1s025ltr.pdf | |
| 07/16/2018 | SUPPL-24 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022187s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022187Orig1s024ltr.pdf | |
| 11/06/2018 | SUPPL-23 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022187s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022187Orig1s023ltr.pdf | |
| 05/20/2016 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/2016 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/2015 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/2014 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022187s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022187Orig1s016ltr.pdf | |
| 07/08/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2013 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf | |
| 04/30/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2013 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf | |
| 02/27/2013 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf | |
| 08/10/2012 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022187Orig1s010ltr.pdf | |
| 03/26/2012 | SUPPL-9 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022187s009ltr.pdf | |
| 10/07/2011 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022187s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022187s008ltr.pdf | |
| 12/22/2010 | SUPPL-7 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s007ltr.pdf | |
| 12/17/2010 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s006ltr.pdf | |
| 02/23/2010 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s003ltr.pdf | |
| 09/15/2009 | SUPPL-2 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022187s002ltr.pdf | |
| 11/24/2009 | SUPPL-1 | Efficacy-Accelerated Approval |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s001lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/10/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022187s025lbl.pdf | |
| 07/10/2019 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022187s025lbl.pdf | |
| 11/06/2018 | SUPPL-23 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022187s023lbl.pdf | |
| 07/16/2018 | SUPPL-24 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022187s024lbl.pdf | |
| 08/20/2014 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022187s016lbl.pdf | |
| 02/27/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf | |
| 02/27/2013 | SUPPL-14 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf | |
| 02/27/2013 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf | |
| 02/27/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf | |
| 02/27/2013 | SUPPL-11 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf | |
| 08/10/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s010lbl.pdf | |
| 03/26/2012 | SUPPL-9 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s009lbl.pdf | |
| 10/07/2011 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022187s008lbl.pdf | |
| 10/07/2011 | SUPPL-8 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022187s008lbl.pdf | |
| 12/22/2010 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s007lbl.pdf | |
| 12/17/2010 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s006lbl.pdf | |
| 12/17/2010 | SUPPL-6 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s006lbl.pdf | |
| 02/23/2010 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s003lbl.pdf | |
| 11/24/2009 | SUPPL-1 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s001lbl.pdf | |
| 09/15/2009 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s002lbl.pdf | |
| 01/18/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022187lbl.pdf |
INTELENCE
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETRAVIRINE | ETRAVIRINE | 100MG | TABLET;ORAL | Prescription | No | AB | 214196 | AMNEAL |
| ETRAVIRINE | ETRAVIRINE | 100MG | TABLET;ORAL | Prescription | No | AB | 215402 | CARNEGIE |
| INTELENCE | ETRAVIRINE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 022187 | JANSSEN R AND D |
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETRAVIRINE | ETRAVIRINE | 200MG | TABLET;ORAL | Prescription | No | AB | 214196 | AMNEAL |
| ETRAVIRINE | ETRAVIRINE | 200MG | TABLET;ORAL | Prescription | No | AB | 215402 | CARNEGIE |
| INTELENCE | ETRAVIRINE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 022187 | JANSSEN R AND D |