Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022187
Company: JANSSEN R AND D
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTELENCE ETRAVIRINE 100MG TABLET;ORAL Prescription None Yes No
INTELENCE ETRAVIRINE 200MG TABLET;ORAL Prescription None Yes Yes
INTELENCE ETRAVIRINE 25MG TABLET;ORAL Prescription 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
01/18/2008 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022187lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022187s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022187TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022187s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/16/2018 SUPPL-24 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022187s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022187Orig1s024ltr.pdf
11/06/2018 SUPPL-23 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022187s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022187Orig1s023ltr.pdf
05/20/2016 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/10/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/06/2015 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/20/2014 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022187s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022187Orig1s016ltr.pdf
07/08/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/27/2013 SUPPL-14 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf
04/30/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/27/2013 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf
02/27/2013 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf
08/10/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022187Orig1s010ltr.pdf
03/26/2012 SUPPL-9 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022187s009ltr.pdf
10/07/2011 SUPPL-8 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022187s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022187s008ltr.pdf
12/22/2010 SUPPL-7 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s007ltr.pdf
12/17/2010 SUPPL-6 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s006ltr.pdf
02/23/2010 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s003ltr.pdf
09/15/2009 SUPPL-2 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022187s002ltr.pdf
11/24/2009 SUPPL-1 Efficacy-Accelerated Approval Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/06/2018 SUPPL-23 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022187s023lbl.pdf
07/16/2018 SUPPL-24 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022187s024lbl.pdf
08/20/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022187s016lbl.pdf
02/27/2013 SUPPL-14 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf
02/27/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf
02/27/2013 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf
02/27/2013 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf
02/27/2013 SUPPL-11 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf
08/10/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s010lbl.pdf
03/26/2012 SUPPL-9 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s009lbl.pdf
10/07/2011 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022187s008lbl.pdf
10/07/2011 SUPPL-8 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022187s008lbl.pdf
12/22/2010 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s007lbl.pdf
12/17/2010 SUPPL-6 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s006lbl.pdf
12/17/2010 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s006lbl.pdf
02/23/2010 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s003lbl.pdf
11/24/2009 SUPPL-1 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s001lbl.pdf
09/15/2009 SUPPL-2 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s002lbl.pdf
01/18/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022187lbl.pdf

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