Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020945
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NORVIR RITONAVIR 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
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-Package Insert, Labeling-Patient 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-Medication Guide, Labeling-Package Insert 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020945s036lbl.pdf
11/07/2013 SUPPL-36 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020945s036lbl.pdf
11/19/2012 SUPPL-35 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s035lbl.pdf
11/19/2012 SUPPL-35 Labeling-Package Insert 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English