Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022145
Company: MSD SUB MERCK
Company: MSD SUB MERCK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISENTRESS | RALTEGRAVIR POTASSIUM | EQ 400MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
ISENTRESS HD | RALTEGRAVIR POTASSIUM | EQ 600MG 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 |
---|---|---|---|---|---|---|---|
10/12/2007 | 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/2007/022145lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022145s000tr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022145_Isentress.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022145_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/18/2021 | SUPPL-44 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022145s044,203045s017,205786s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022145Orig1s044;203045Orig1s017;205786Orig1s009ltr.pdf | |
07/14/2020 | SUPPL-42 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022145s042,203045s016,205786s008lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203045Orig1s016;022145Orig1s042;205786Orig1s008replacementltr.pdf | |
06/15/2018 | SUPPL-39 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022145Orig1s039ltr.pdf | |
03/05/2018 | SUPPL-38 | Efficacy-Labeling Change With Clinical Data |
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-37 | 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-36 | 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-35 | 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-34 | 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 | |
10/10/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/08/2014 | SUPPL-32 | 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-31 | 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-30 | Labeling-Package Insert, Labeling-Patient Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s030,203045Orig1s008ltr.pdf |
08/05/2013 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s029,203045Orig1s007ltr.pdf | |
04/04/2013 | SUPPL-28 | 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-27 | 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-26 | 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-23 | 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 | |
12/21/2011 | SUPPL-22 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s022ltr.pdf | |
03/28/2012 | SUPPL-21 | 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 | |
11/02/2011 | SUPPL-20 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s020ltr.pdf | |
04/11/2011 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s018ltr.pdf | |
02/24/2011 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s017ltr.pdf | |
06/10/2011 | SUPPL-15 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf |
03/26/2010 | SUPPL-14 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s014ltr.pdf | |
11/04/2009 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s013ltr.pdf | |
06/29/2010 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s011,s012ltr.pdf | |
06/29/2010 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s011,s012ltr.pdf | |
01/13/2009 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s006ltr.pdf | |
07/08/2009 | SUPPL-4 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022145Orig1s004.pdf | |
10/24/2008 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022145s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022145s003ltr.pdf | |
01/29/2009 | SUPPL-1 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001altr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/18/2021 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022145s044,203045s017,205786s009lbl.pdf | |
05/18/2021 | SUPPL-44 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022145s044,203045s017,205786s009lbl.pdf | |
07/14/2020 | SUPPL-42 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022145s042,203045s016,205786s008lblrpl.pdf | |
03/05/2018 | SUPPL-38 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022145s038,205786s007,0203045s015lbl.pdf | |
11/22/2017 | SUPPL-37 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s037,203045s014,205786s006lbl.pdf | |
05/26/2017 | SUPPL-36 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022145s036,203045s013,205786s004lbl.pdf | |
02/20/2015 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s035,203045s012,205786s003lbl.pdf | |
02/18/2015 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205786s002lbl.pdf | |
04/08/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,205786s001lbl.pdf | |
12/20/2013 | SUPPL-31 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205786s000,022145s031,203045s009lbl.pdf | |
08/05/2013 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s029lbl.pdf | |
06/28/2013 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s027,203045s004lbl.pdf | |
04/04/2013 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s028,203045s005lbl.pdf | |
08/10/2012 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203045s003,022145s026lbl.pdf | |
04/18/2012 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s023,203045s002lbl.pdf | |
03/28/2012 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s021,203045s001lbl.pdf | |
12/21/2011 | SUPPL-22 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s022lbl.pdf | |
11/02/2011 | SUPPL-20 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s020lbl.pdf | |
11/02/2011 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s020lbl.pdf | |
04/11/2011 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s018lbl.pdf | |
02/24/2011 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s017lbl.pdf | |
06/29/2010 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf | |
06/29/2010 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf | |
03/26/2010 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s014lbl.pdf | |
11/04/2009 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s013lbl.pdf | |
07/08/2009 | SUPPL-4 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s004lbl.pdf | |
01/29/2009 | SUPPL-1 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s001lbl.pdf | |
01/13/2009 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s006lbl.pdf | |
10/24/2008 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022145s003lbl.pdf | |
10/12/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022145lbl.pdf |
ISENTRESS
TABLET;ORAL; EQ 400MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISENTRESS | RALTEGRAVIR POTASSIUM | EQ 400MG BASE | TABLET;ORAL | Prescription | Yes | AB | 022145 | MSD SUB MERCK |
RALTEGRAVIR POTASSIUM | RALTEGRAVIR POTASSIUM | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 203540 | HETERO LABS LTD III |
ISENTRESS HD
There are no Therapeutic Equivalents.