Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021814
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| APTIVUS | TIPRANAVIR | 250MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/22/2005 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021814lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021814ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21814_000_AptivusTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/03/2024 | SUPPL-30 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021814s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021814Orig1s030ltr.pdf | |
| 06/18/2020 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021814s021,022292s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022292Orig1s014,021814Orig1s021ltr.pdf | |
| 06/22/2018 | SUPPL-18 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021814s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022292Orig1s010,021814Orig1s018ltr.pdf | |
| 09/15/2016 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021814s016,022292s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021814Orig1s016,022292Orig1s009ltr.pdf | |
| 03/27/2015 | SUPPL-15 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021814Orig1s015,022292Orig1s008ltr.pdf | |
| 04/07/2014 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021814s014,022292s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021814Origs014,022292Orig1s007ltr.pdf | |
| 02/17/2012 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021814s013,022292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021814s013,022292s006ltr.pdf | |
| 04/05/2011 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021814s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021814s011,022292s004ltr.pdf | |
| 08/16/2010 | SUPPL-9 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s009,022292s003ltr.pdf | |
| 04/27/2010 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s008,022292s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s008,022292s002ltr.pdf | |
| 06/19/2009 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021814s006,022292s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021814s006,022292s001ltr.pdf | |
| 06/23/2008 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021814s005,022292lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021814s005, 022292s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005, 022292_aptivus_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005,%2022-292s000sumr.pdf | |
| 05/14/2007 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021814s004ltr.pdf |
| 10/04/2007 | SUPPL-3 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021814s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021814s003ltr.pdf | |
| 08/11/2006 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021814s001, 021814s002LTR.pdf | |
| 08/11/2006 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021814s001, 021814s002LTR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/03/2024 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021814s030lbl.pdf | |
| 04/03/2024 | SUPPL-30 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021814s030lbl.pdf | |
| 06/18/2020 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021814s021,022292s014lbl.pdf | |
| 06/18/2020 | SUPPL-21 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021814s021,022292s014lbl.pdf | |
| 06/22/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021814s018lbl.pdf | |
| 06/22/2018 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021814s018lbl.pdf | |
| 09/15/2016 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021814s016,022292s009lbl.pdf | |
| 03/27/2015 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf | |
| 03/27/2015 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf | |
| 04/07/2014 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021814s014,022292s007lbl.pdf | |
| 02/17/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021814s013,022292s006lbl.pdf | |
| 04/05/2011 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021814s011lbl.pdf | |
| 08/16/2010 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s009lbl.pdf | |
| 04/27/2010 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s008,022292s002lbl.pdf | |
| 06/19/2009 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021814s006,022292s001lbl.pdf | |
| 06/23/2008 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021814s005,022292lbl.pdf | |
| 10/04/2007 | SUPPL-3 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021814s003lbl.pdf | |
| 08/11/2006 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf | |
| 08/11/2006 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf | |
| 06/22/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021814lbl.pdf |