Documents
Application Sponsors
| NDA 022145 | MERCK SHARP DOHME | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 400MG BASE | 1 | ISENTRESS | RALTEGRAVIR POTASSIUM |
| 002 | TABLET;ORAL | EQ 600MG BASE | 1 | ISENTRESS HD | RALTEGRAVIR POTASSIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2007-10-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2008-10-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2009-07-08 | UNKNOWN |
| LABELING; Labeling | SUPPL | 6 | AP | 2009-01-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2010-06-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2010-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2009-11-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 14 | AP | 2010-03-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 15 | AP | 2011-06-10 | UNKNOWN |
| LABELING; Labeling | SUPPL | 17 | AP | 2011-02-24 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2011-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2011-11-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2012-03-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 22 | AP | 2011-12-21 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2012-04-18 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2012-08-10 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2013-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2013-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2013-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2013-10-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 31 | AP | 2013-12-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 32 | AP | 2014-04-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2014-10-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 34 | AP | 2015-02-18 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2015-02-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2017-05-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 37 | AP | 2017-11-22 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 38 | AP | 2018-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2018-06-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 42 | AP | 2020-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2021-05-18 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 10 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 17 | Null | 31 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 38 | Null | 7 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 44 | Null | 15 |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 22145
[companyName] => MERCK SHARP DOHME
[docInserts] => ["",""]
[products] => [{"drugName":"ISENTRESS","activeIngredients":"RALTEGRAVIR POTASSIUM","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ISENTRESS HD","activeIngredients":"RALTEGRAVIR POTASSIUM","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/14\/2020","submission":"SUPPL-42","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022145s042,203045s016,205786s008lblrpl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2018","submission":"SUPPL-38","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022145s038,205786s007,0203045s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2017","submission":"SUPPL-37","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022145s034l,203045s011,205786s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2014","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022145s032,203045s010,205786s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2013","submission":"SUPPL-31","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/205786s000,022145s031,203045s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2013","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022145s029lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-27","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022145s027,203045s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2013","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022145s028,203045s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2012","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203045s003,022145s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2012","submission":"SUPPL-23","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022145s023,203045s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2012","submission":"SUPPL-21","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022145s021,203045s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2011","submission":"SUPPL-22","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022145s022lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2011","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022145s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2011","submission":"SUPPL-20","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022145s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2011","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022145s018lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2011","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022145s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2010","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022145s011s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2010","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022145s011s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2010","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022145s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2009","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022145s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2009","submission":"SUPPL-4","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022145s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2009","submission":"SUPPL-1","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022145s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2009","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022145s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2008","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022145s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022145lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ISENTRESS","submission":"RALTEGRAVIR POTASSIUM","actionType":"EQ 400MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ISENTRESS HD","submission":"RALTEGRAVIR POTASSIUM","actionType":"EQ 600MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-07-14
)
)