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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020659
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORVIR RITONAVIR 80MG/ML SOLUTION;ORAL Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/21/2020 SUPPL-72 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020659s072,022417s024,209512s007lbl.pdf
10/21/2020 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020659s072,022417s024,209512s007lbl.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
12/19/2019 SUPPL-71 Labeling-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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf
09/29/2017 SUPPL-68 Labeling-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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659S063_022417S15lbl.pdf
11/22/2016 SUPPL-63 Labeling-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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s062,022417s014lbl.pdf
11/10/2015 SUPPL-62 Labeling-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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022417s008,020659s057lbl.pdf
11/20/2012 SUPPL-57 Labeling-Patient 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
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