Drugs@FDA: FDA-Approved Drugs
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORVIR | RITONAVIR | 80MG/ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
03/01/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020659Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2022 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022417Orig1s025,020659Orig1s073,209512Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022417Orig1s025;020659Orig1s073;209512Orig1s008ltr.pdf | |
10/21/2020 | SUPPL-72 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020659s072,022417s024,209512s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020659Orig1s072, 022417Orig1s024, 209512Orig1s007ltr.pdf | |
12/19/2019 | SUPPL-71 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s071, 209512s006, 022417s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020659Orig1s071, 209512Orig1s006, 022417Orig1s023ltr.pdf | |
08/21/2019 | SUPPL-70 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s070,022417s022,209512s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020659Orig1s070, 209512Orig1s005, 022417Orig1s022ltr.pdf | |
11/15/2018 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020659s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020659Orig1s069,022417Orig1s021,0209512Orig1s004ltr.pdf | |
09/29/2017 | SUPPL-68 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209512Orig1s002,022417Origs020,020659Orig1s068ltr.pdf | |
06/07/2017 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022417s19_020659s67lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020659Orig1s067,022417Orig1s019ltr.pdf | |
06/29/2017 | SUPPL-66 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020659Orig1s066,022417Orig1s018,209512Orig1s001ltr.pdf | |
09/15/2016 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s065,022417s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022417s017,020659Orig1s065ltr.pdf | |
12/22/2016 | SUPPL-64 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s064,022417s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020659Orig1s064022417Orig1s016ltr.pdf | |
11/22/2016 | SUPPL-63 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659S063_022417S15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020659Orig1s063,022417Orig1s015ltr.pdf | |
11/10/2015 | SUPPL-62 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s062,022417s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020659Orig1s062,022417Orig1s14ltr.pdf | |
03/27/2015 | SUPPL-61 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022417s013,020659s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s013,020659Orig1s061ltr.pdf | |
03/16/2015 | SUPPL-60 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s012,020659Orig1s060ltr.pdf | |
11/07/2013 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020659s058_022417s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020659Orig1s058,022417Orig1s010ltr.pdf | |
11/20/2012 | SUPPL-57 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022417s008,020659s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022417Orig1s008,020659Orig1s057ltr.pdf | |
02/17/2012 | SUPPL-56 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020659s056,022417s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020659s056,022417s007ltr.pdf | |
12/06/2011 | SUPPL-55 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020659s055,022417s006ltr.pdf | |
04/27/2010 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s050,022417s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020659s050,022417s001ltr.pdf | |
11/23/2009 | SUPPL-47 | 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 | |
02/10/2010 | SUPPL-45 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020659s045ltr.pdf | |
10/01/2008 | SUPPL-43 | 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-42 | 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-40 | 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-39 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s039ltr.pdf |
05/10/2007 | SUPPL-36 | 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-34 | 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/2005/020659_S034_NORVIR.pdf | |
11/09/2005 | SUPPL-33 | 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/2005/020659_S033_NORVIR.pdf | |
03/28/2005 | SUPPL-32 | 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-30 | 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-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/14/2002 | SUPPL-27 | 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-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20659s26ltr.pdf |
08/21/2001 | SUPPL-25 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf | |
09/01/2000 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/08/2000 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
10/26/1999 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
10/21/1999 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
10/28/1999 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/09/1999 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
04/12/1999 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
02/26/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/30/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
09/25/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/24/1998 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/26/1999 | SUPPL-13 | Efficacy-Accelerated Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020659s013_020680s011_Norvir.cfm |
02/12/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
05/01/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/23/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/31/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
03/14/1997 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
05/09/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/17/1997 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/08/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
09/24/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
10/01/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/01/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/15/2022 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022417Orig1s025,020659Orig1s073,209512Orig1s008lbl.pdf | |
10/21/2020 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020659s072,022417s024,209512s007lbl.pdf | |
10/21/2020 | SUPPL-72 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020659s072,022417s024,209512s007lbl.pdf | |
12/19/2019 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s071, 209512s006, 022417s023lbl.pdf | |
12/19/2019 | SUPPL-71 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s071, 209512s006, 022417s023lbl.pdf | |
08/21/2019 | SUPPL-70 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s070,022417s022,209512s005lbl.pdf | |
08/21/2019 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s070,022417s022,209512s005lbl.pdf | |
11/15/2018 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020659s069lbl.pdf | |
09/29/2017 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf | |
09/29/2017 | SUPPL-68 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf | |
06/29/2017 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf | |
06/29/2017 | SUPPL-66 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf | |
06/07/2017 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022417s19_020659s67lbl.pdf | |
12/22/2016 | SUPPL-64 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s064,022417s016lbl.pdf | |
12/22/2016 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s064,022417s016lbl.pdf | |
11/22/2016 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659S063_022417S15lbl.pdf | |
11/22/2016 | SUPPL-63 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659S063_022417S15lbl.pdf | |
09/15/2016 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s065,022417s017lbl.pdf | |
11/10/2015 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s062,022417s014lbl.pdf | |
11/10/2015 | SUPPL-62 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s062,022417s014lbl.pdf | |
03/27/2015 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022417s013,020659s061lbl.pdf | |
03/27/2015 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022417s013,020659s061lbl.pdf | |
03/16/2015 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.pdf | |
03/16/2015 | SUPPL-60 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.pdf | |
11/07/2013 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020659s058_022417s010lbl.pdf | |
11/20/2012 | SUPPL-57 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022417s008,020659s057lbl.pdf | |
11/20/2012 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022417s008,020659s057lbl.pdf | |
02/17/2012 | SUPPL-56 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020659s056,022417s007lbl.pdf | |
12/06/2011 | SUPPL-55 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.pdf | |
12/06/2011 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.pdf | |
04/27/2010 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s050,022417s001lbl.pdf | |
02/10/2010 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s045lbl.pdf | |
11/23/2009 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020945s026,020659s047lbl.pdf | |
10/01/2008 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020659s043,020945s023lbl.pdf | |
08/29/2008 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020945s022,020659s042lbl.pdf | |
07/31/2007 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s040,020945s020lbl.pdf | |
05/10/2007 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s036,020945s018lbl.pdf | |
11/09/2005 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020945s016,020659s033lbl.pdf | |
10/06/2005 | SUPPL-34 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020659s034,020945s017lbl.pdf | |
03/28/2005 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20659s032,20945s014lbl.pdf | |
09/10/2003 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20659slr030,20945slr013_norvir_lbl.pdf | |
03/14/2002 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20659S27lbl.pdf | |
08/21/2001 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf |