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 |
| 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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.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-12 | 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 | |
| 02/27/2013 | SUPPL-11 | Labeling-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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022187s008lbl.pdf | |
| 10/07/2011 | SUPPL-8 | Labeling-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 |