Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020945
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORVIR | RITONAVIR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/29/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945.pdf_Ritonovir_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945.pdf_Ritonovir_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945_Ritonovir.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/21/2020 | SUPPL-48 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020945s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020945Orig1s048ltr.pdf | |
| 12/19/2019 | SUPPL-47 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020945s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020945Orig1s047ltr.pdf | |
| 08/21/2019 | SUPPL-46 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020945s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020945Orig1s046ltr.pdf | |
| 11/15/2018 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020945s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020945Orig1s045ltr.pdf | |
| 06/29/2017 | SUPPL-44 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020945s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020945Orig1s044ltr.pdf | |
| 09/15/2016 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020945Orig1s043ltr.pdf | |
| 12/22/2016 | SUPPL-42 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020945Orig1s042ltr.pdf | |
| 11/22/2016 | SUPPL-41 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020945Orig1s041ltr.pdf | |
| 11/10/2015 | SUPPL-40 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s040ltr.pdf | |
| 03/27/2015 | SUPPL-39 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s039ltr.pdf | |
| 03/16/2015 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s038ltr.pdf | |
| 11/07/2013 | SUPPL-36 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020945s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020945Orig1s036ltr.pdf | |
| 11/19/2012 | SUPPL-35 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945Orig1s035ltr.pdf | |
| 02/17/2012 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945s034ltr.pdf | |
| 03/29/2012 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945s033ltr.pdf | |
| 12/06/2011 | SUPPL-32 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020945s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020945s032ltr.pdf | |
| 04/27/2010 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020945s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020945s028ltr.pdf | |
| 11/23/2009 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020945s026,020659s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020945s026,020659s047ltr.pdf | |
| 10/01/2008 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020659s043,020945s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s043, 020945s023ltr.pdf | |
| 08/29/2008 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020945s022,020659s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020945s022, 020659s042ltr.pdf | |
| 07/31/2007 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s040,020945s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s040, 020945s020ltr.pdf | |
| 05/16/2008 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020945s019ltr.pdf |
| 05/10/2007 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s036,020945s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s036,020945s018ltr.pdf | |
| 10/06/2005 | SUPPL-17 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020659s034,020945s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020659s034,020945s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020945_S017_NORVIR.pdf | |
| 11/09/2005 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020945s016,020659s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020945s016,020659s033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020945_S016_NORVIR.pdf | |
| 03/28/2005 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20659s032,20945s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20659s032,20945s014ltr.pdf | |
| 09/10/2003 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20659slr030,20945slr013_norvir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20659slr030,20945slr013ltr.pdf | |
| 12/24/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/2002 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/17/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/2002 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20659S27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20659s27ltr.pdf | |
| 03/06/2001 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20659s26ltr.pdf |
| 02/05/2001 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/21/2001 | SUPPL-5 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf | |
| 05/08/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/23/1999 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/26/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/21/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/21/2020 | SUPPL-48 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020945s048lbl.pdf | |
| 10/21/2020 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020945s048lbl.pdf | |
| 12/19/2019 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020945s047lbl.pdf | |
| 12/19/2019 | SUPPL-47 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020945s047lbl.pdf | |
| 08/21/2019 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020945s046lbl.pdf | |
| 08/21/2019 | SUPPL-46 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020945s046lbl.pdf | |
| 11/15/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020945s045lbl.pdf | |
| 06/29/2017 | SUPPL-44 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020945s044lbl.pdf | |
| 06/29/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020945s044lbl.pdf | |
| 12/22/2016 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s042lbl.pdf | |
| 12/22/2016 | SUPPL-42 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s042lbl.pdf | |
| 11/22/2016 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s041lbl.pdf | |
| 11/22/2016 | SUPPL-41 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s041lbl.pdf | |
| 09/15/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s043lbl.pdf | |
| 11/10/2015 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s040lbl.pdf | |
| 11/10/2015 | SUPPL-40 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s040lbl.pdf | |
| 03/27/2015 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s039lbl.pdf | |
| 03/27/2015 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s039lbl.pdf | |
| 03/16/2015 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s038lbl.pdf | |
| 03/16/2015 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s038lbl.pdf | |
| 11/07/2013 | SUPPL-36 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020945s036lbl.pdf | |
| 11/07/2013 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020945s036lbl.pdf | |
| 11/19/2012 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s035lbl.pdf | |
| 11/19/2012 | SUPPL-35 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s035lbl.pdf | |
| 03/29/2012 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s033lbl.pdf | |
| 02/17/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s034lbl.pdf | |
| 12/06/2011 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020945s032lbl.pdf | |
| 12/06/2011 | SUPPL-32 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020945s032lbl.pdf | |
| 04/27/2010 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020945s028lbl.pdf | |
| 11/23/2009 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020945s026,020659s047lbl.pdf | |
| 10/01/2008 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020659s043,020945s023lbl.pdf | |
| 08/29/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020945s022,020659s042lbl.pdf | |
| 07/31/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s040,020945s020lbl.pdf | |
| 05/10/2007 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s036,020945s018lbl.pdf | |
| 11/09/2005 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020945s016,020659s033lbl.pdf | |
| 10/06/2005 | SUPPL-17 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020659s034,020945s017lbl.pdf | |
| 03/28/2005 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20659s032,20945s014lbl.pdf | |
| 09/10/2003 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20659slr030,20945slr013_norvir_lbl.pdf | |
| 03/14/2002 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20659S27lbl.pdf | |
| 08/21/2001 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf | |
| 06/29/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945.pdf_Ritonovir_Prntlbl.pdf |