Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021976
Company: JANSSEN PRODS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREZISTA DARUNAVIR ETHANOLATE EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
PREZISTA DARUNAVIR ETHANOLATE EQ 600MG BASE TABLET;ORAL Prescription AB Yes No
PREZISTA DARUNAVIR ETHANOLATE EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
PREZISTA DARUNAVIR ETHANOLATE EQ 75MG BASE TABLET;ORAL Prescription None Yes No
PREZISTA DARUNAVIR ETHANOLATE EQ 150MG BASE TABLET;ORAL Prescription None Yes No
PREZISTA DARUNAVIR ETHANOLATE EQ 800MG BASE TABLET;ORAL Prescription None 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
06/23/2006 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021976s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021976s000_SprycelTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/31/2019 SUPPL-54 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s054,202895s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021976Orig1s054, 202895Orig1s025ltr.pdf
03/21/2019 SUPPL-53 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s053,202895s024lbl.pdf
09/07/2018 SUPPL-51 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s051,202895s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202895Orig1s51,021976Orig1s022Ltr.pdf
01/25/2018 SUPPL-47 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s047_202895S021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021976Orig1s047,202895Orig1s021ltr.pdf
06/19/2017 SUPPL-45 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021976s045_202895s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021976Orig1s045,202895Orig1s020ltr.pdf
09/15/2016 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s044,202895s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s044,202895Orig1s019ltr.pdf
06/17/2016 SUPPL-43 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s043,202895Orig1s017ltr.pdf
04/11/2016 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/27/2015 SUPPL-39 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s039,202895Orig1s016ltr.pdf
02/19/2016 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/27/2015 SUPPL-36 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s036,202895Orig1s013ltr.pdf
05/08/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/07/2014 SUPPL-34 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021976Orig1s034,202895Orig1s011_replace_ltr.pdf
11/07/2013 SUPPL-33 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s033,202895Orig1s010ltr.pdf
10/31/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/14/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/22/2013 SUPPL-30 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s030,202895Orig1s007ltr.pdf
02/01/2013 SUPPL-29 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s029,202895Orig1s006ltr.pdf
02/01/2013 SUPPL-28 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s028,202895Orig1s005ltr.pdf
04/24/2013 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202895Orig1s004,021976Orig1s027ltr.pdf
06/01/2012 SUPPL-26 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s026,202895s002ltr.pdf
11/09/2012 SUPPL-25 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s025lbl.pdf
02/17/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s022ltr.pdf
02/13/2012 SUPPL-21 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s021ltr.pdf
12/16/2011 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202895,021976s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202895s000,021976s020ltr.pdf
10/19/2011 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021976s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021976s018ltr.pdf
12/13/2010 SUPPL-17 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s017ltr.pdf
04/26/2010 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s016ltr.pdf
01/27/2010 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s012s013ltr.pdf
01/27/2010 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s012s013ltr.pdf
06/15/2009 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021976s011ltr.pdf
06/15/2009 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021976s010ltr.pdf
12/18/2008 SUPPL-9 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s009ltr.pdf
10/21/2008 SUPPL-7 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s007ltr.pdf
10/21/2008 SUPPL-6 Efficacy-Accelerated Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s006ltr.pdf
02/25/2008 SUPPL-5 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s005ltr.pdf
03/07/2008 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s003, 021976s004ltr.pdf
03/07/2008 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s003, 021976s004ltr.pdf
04/25/2007 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/20/2006 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021976s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/21/2019 SUPPL-53 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s053,202895s024lbl.pdf
01/31/2019 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s054,202895s025lbl.pdf
01/31/2019 SUPPL-54 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s054,202895s025lbl.pdf
09/07/2018 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s051,202895s022lbl.pdf
09/07/2018 SUPPL-51 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s051,202895s022lbl.pdf
01/25/2018 SUPPL-47 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s047_202895S021lbl.pdf
01/25/2018 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s047_202895S021lbl.pdf
06/19/2017 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021976s045_202895s020lbl.pdf
06/19/2017 SUPPL-45 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021976s045_202895s020lbl.pdf
09/15/2016 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s044,202895s019lbl.pdf
06/17/2016 SUPPL-43 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf
05/27/2015 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf
05/27/2015 SUPPL-36 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf
03/27/2015 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf
03/27/2015 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf
04/07/2014 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf
04/07/2014 SUPPL-34 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf
11/07/2013 SUPPL-33 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf
11/07/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf
04/24/2013 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.pdf
02/22/2013 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf
02/22/2013 SUPPL-30 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf
02/01/2013 SUPPL-29 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.pdf
02/01/2013 SUPPL-28 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.pdf
11/09/2012 SUPPL-25 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s025lbl.pdf
06/01/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf
06/01/2012 SUPPL-26 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf
02/17/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s022lbl.pdf
02/13/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s021lbl.pdf
02/13/2012 SUPPL-21 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s021lbl.pdf
12/16/2011 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202895,021976s020lbl.pdf
10/19/2011 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021976s018lbl.pdf
12/13/2010 SUPPL-17 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s017lbl.pdf
04/26/2010 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s016lbl.pdf
01/27/2010 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf
01/27/2010 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf
06/15/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s011lbl.pdf
06/15/2009 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s010lbl.pdf
12/18/2008 SUPPL-9 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s009lbl.pdf
10/21/2008 SUPPL-7 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s007lbl.pdf
03/07/2008 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf
03/07/2008 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf
02/25/2008 SUPPL-5 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s005lbl.pdf
11/20/2006 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976s001lbl.pdf
06/23/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976lbl.pdf

PREZISTA

TABLET;ORAL; EQ 600MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DARUNAVIR ETHANOLATE DARUNAVIR ETHANOLATE EQ 600MG BASE TABLET;ORAL Prescription No AB 202118 TEVA PHARMS USA
PREZISTA DARUNAVIR ETHANOLATE EQ 600MG BASE TABLET;ORAL Prescription Yes AB 021976 JANSSEN PRODS

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