Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203045
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISENTRESS RALTEGRAVIR POTASSIUM EQ 25MG BASE TABLET, CHEWABLE;ORAL Prescription None Yes No
ISENTRESS RALTEGRAVIR POTASSIUM EQ 100MG BASE TABLET, CHEWABLE;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
12/21/2011 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/203045s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/203045s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/203045_isentress_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/203045Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/05/2018 SUPPL-15 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022145s038,205786s007,0203045s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022145Orig1s038,205786Orig1s007,203045Orig2s015ltr.pdf
11/22/2017 SUPPL-14 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s037,203045s014,205786s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205786Orig1s006,022145Orig1s037,203045Orig1s014ltr.pdf
05/26/2017 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s036,203045s013,205786s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022145Orig1s036,203045Orig1s013,205786Orig1s004ltr.pdf
02/20/2015 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s035,203045s012,205786s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045Orig1s012,022145Orig1s035ltr.pdf
02/18/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205786s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045Orig1s011,022145Orig1s034ltr.pdf
04/08/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,205786s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045Orig1s010,205786Orig1s001ltr.pdf
12/20/2013 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205786s000,022145s031,203045s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145Orig1s031,203045Orig1s009ltr.pdf
10/24/2013 SUPPL-8 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s030,203045Orig1s008ltr.pdf
08/05/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s029,203045Orig1s007ltr.pdf
05/28/2013 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/04/2013 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s028,203045s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s028,203045Orig1s005ltr.pdf
06/28/2013 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s027,203045s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s027,203045Orig1s004ltr_replace.pdf
08/10/2012 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203045s003,022145s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145Orig1s026,203045Orig1s003ltr.pdf
04/18/2012 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s023,203045s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s023,203045s002ltr.pdf
03/28/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s021,203045s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s021,0203045s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/05/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022145s038,205786s007,0203045s015lbl.pdf
03/05/2018 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022145s038,205786s007,0203045s015lbl.pdf
11/22/2017 SUPPL-14 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s037,203045s014,205786s006lbl.pdf
05/26/2017 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s036,203045s013,205786s004lbl.pdf
02/20/2015 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s035,203045s012,205786s003lbl.pdf
02/18/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205786s002lbl.pdf
04/08/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,205786s001lbl.pdf
12/20/2013 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205786s000,022145s031,203045s009lbl.pdf
10/24/2013 SUPPL-8 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s008lbl.pdf
10/24/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s008lbl.pdf
08/05/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s007lbl.pdf
06/28/2013 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s027,203045s004lbl.pdf
04/04/2013 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s028,203045s005lbl.pdf
08/10/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203045s003,022145s026lbl.pdf
04/18/2012 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s023,203045s002lbl.pdf
03/28/2012 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s021,203045s001lbl.pdf
12/21/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/203045s000lbl.pdf

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