Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022417
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORVIR RITONAVIR 100MG TABLET;ORAL Prescription AB 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
02/10/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022417lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022417s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022417s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022417s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2018 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022417s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020659Orig1s069,022417Orig1s021,0209512Orig1s004ltr.pdf
09/29/2017 SUPPL-20 Labeling-Patient Package Insert, Labeling-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-19 Labeling-Package Insert, Labeling-Patient 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-18 Labeling-Medication Guide, Labeling-Package Insert 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-17 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/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022417s017,020659Orig1s065ltr.pdf
12/22/2016 SUPPL-16 Labeling-Package Insert, Labeling-Patient 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-15 Labeling-Patient Package Insert, Labeling-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-14 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-13 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-12 Labeling-Medication Guide, Labeling-Package Insert 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-10 Labeling-Patient Package Insert, 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-8 Labeling-Package Insert, Labeling-Patient 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-7 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-6 Labeling-Package Insert, Labeling-Patient 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-1 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2018 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022417s021lbl.pdf
09/29/2017 SUPPL-20 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf
09/29/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf
06/29/2017 SUPPL-18 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf
06/29/2017 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf
06/07/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022417s19_020659s67lbl.pdf
06/07/2017 SUPPL-19 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022417s19_020659s67lbl.pdf
12/22/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s064,022417s016lbl.pdf
12/22/2016 SUPPL-16 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s064,022417s016lbl.pdf
11/22/2016 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659S063_022417S15lbl.pdf
11/22/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659S063_022417S15lbl.pdf
09/15/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s065,022417s017lbl.pdf
11/10/2015 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s062,022417s014lbl.pdf
11/10/2015 SUPPL-14 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s062,022417s014lbl.pdf
03/27/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022417s013,020659s061lbl.pdf
03/16/2015 SUPPL-12 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.pdf
03/16/2015 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.pdf
11/07/2013 SUPPL-10 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020659s058_022417s010lbl.pdf
11/07/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020659s058_022417s010lbl.pdf
11/20/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022417s008,020659s057lbl.pdf
11/20/2012 SUPPL-8 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022417s008,020659s057lbl.pdf
02/17/2012 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020659s056,022417s007lbl.pdf
12/06/2011 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.pdf
12/06/2011 SUPPL-6 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.pdf
04/27/2010 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s050,022417s001lbl.pdf
02/10/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022417lbl.pdf

NORVIR

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORVIR RITONAVIR 100MG TABLET;ORAL Prescription Yes AB 022417 ABBVIE
RITONAVIR RITONAVIR 100MG TABLET;ORAL Prescription No AB 208890 AMNEAL PHARMS LLC
RITONAVIR RITONAVIR 100MG TABLET;ORAL Prescription No AB 206614 AUROBINDO PHARMA LTD
RITONAVIR RITONAVIR 100MG TABLET;ORAL Prescription No AB 204587 HETERO LABS LTD III
RITONAVIR RITONAVIR 100MG TABLET;ORAL Prescription No AB 202573 WEST-WARD PHARMS INT

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