Documents
Application Sponsors
| NDA 205786 | MERCK SHARP DOHME | |
Marketing Status
Application Products
| 001 | POWDER;ORAL | EQ 100MG BASE/PACKET | 1 | ISENTRESS | RALTEGRAVIR POTASSIUM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2013-12-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-02-18 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-02-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2017-05-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2017-11-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2018-03-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2020-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-05-18 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 205786
[companyName] => MERCK SHARP DOHME
[docInserts] => ["",""]
[products] => [{"drugName":"ISENTRESS","activeIngredients":"RALTEGRAVIR POTASSIUM","strength":"EQ 100MG BASE\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
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[originalApprovals] => [{"actionDate":"12\/20\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/205786s000,022145s031,203045s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/205786Orig1s000,022145Orig1s031,203045Orig1s009ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/205786Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/205786Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"07\/14\/2020","submission":"SUPPL-8","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022145s042,203045s016,205786s008lblrpl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203045Orig1s016;022145Orig1s042;205786Orig1s008replacementltr.pdf\"}]","notes":">"},{"actionDate":"03\/05\/2018","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022145s038,205786s007,0203045s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/022145Orig1s038,205786Orig1s007,203045Orig2s015ltr.pdf\"}]","notes":">"},{"actionDate":"11\/22\/2017","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022145s037,203045s014,205786s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205786Orig1s006,022145Orig1s037,203045Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022145s036,203045s013,205786s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/022145Orig1s036,203045Orig1s013,205786Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"02\/20\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022145s035,203045s012,205786s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205786Orig1s003,203045Orig1s012,022145Orig1s035ltr.pdf\"}]","notes":">"},{"actionDate":"02\/18\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022145s034l,203045s011,205786s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205786Orig1s002,203045Orig1s011,022145Orig1s034ltr.pdf\"}]","notes":">"},{"actionDate":"04\/08\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022145s032,203045s010,205786s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/022145Orig1s032,203045Orig1s010,205786Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-07-14
)
)