MERCK SHARP DOHME FDA Approval NDA 202270

NDA 202270

MERCK SHARP DOHME

FDA Drug Application

Application #202270

Documents

Letter2012-02-06
Letter2012-10-22
Letter2013-02-13
Letter2015-04-29
Label2012-02-06
Label2012-10-22
Label2015-09-04
Summary Review2013-09-03
Letter2014-02-13
Letter2015-09-01
Label2013-02-11
Label2014-02-13
Label2015-05-04
Review2013-09-03
Label2017-01-18
Label2017-01-18
Letter2017-01-24
Letter2017-01-24
Label2017-08-14
Letter2017-08-15
Label2018-02-12
Medication Guide2018-02-12
Letter2018-02-14
Letter2019-07-02
Label2019-07-09
Letter2019-08-13
Label2019-08-13
Label2020-12-04
Letter2020-12-08
Medication Guide2020-12-09
Letter2021-11-05
Label2021-11-08
Letter2022-06-22
Label2022-06-24
Medication Guide2022-06-24

Application Sponsors

NDA 202270MERCK SHARP DOHME

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG;EQ 50MG BASE1JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
002TABLET, EXTENDED RELEASE;ORAL1GM;EQ 50MG BASE1JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
003TABLET, EXTENDED RELEASE;ORAL1GM;EQ 100MG BASE1JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2012-02-02STANDARD
LABELING; LabelingSUPPL2AP2012-10-18UNKNOWN
LABELING; LabelingSUPPL3AP2013-02-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2013-07-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2013-10-17STANDARD
LABELING; LabelingSUPPL6AP2014-02-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2014-09-19STANDARD
LABELING; LabelingSUPPL9AP2015-04-27STANDARD
LABELING; LabelingSUPPL10AP2015-08-28901 REQUIRED
LABELING; LabelingSUPPL15AP2017-01-18901 REQUIRED
LABELING; LabelingSUPPL16AP2017-01-18STANDARD
LABELING; LabelingSUPPL17AP2017-08-10STANDARD
LABELING; LabelingSUPPL18AP2018-02-09STANDARD
EFFICACY; EfficacySUPPL19AP2019-08-12STANDARD
LABELING; LabelingSUPPL20AP2019-07-01901 REQUIRED
EFFICACY; EfficacySUPPL22AP2020-12-04PRIORITY
LABELING; LabelingSUPPL25AP2021-11-04STANDARD
LABELING; LabelingSUPPL26AP2022-06-21STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null6
SUPPL4Null0
SUPPL5Null0
SUPPL6Null15
SUPPL8Null0
SUPPL9Null6
SUPPL10Null6
SUPPL15Null15
SUPPL16Null6
SUPPL17Null7
SUPPL18Null7
SUPPL19Null15
SUPPL20Null6
SUPPL22Null6
SUPPL25Null15
SUPPL26Null7

CDER Filings

MERCK SHARP DOHME
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202270
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/202270s018lbl.pdf#page=32"]
            [products] => [{"drugName":"JANUMET XR","activeIngredients":"METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE","strength":"500MG;EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JANUMET XR","activeIngredients":"METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE","strength":"1GM;EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JANUMET XR","activeIngredients":"METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE","strength":"1GM;EQ 100MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/12\/2019","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202270s019lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202270s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202270s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202270s017lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202270s015s016lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202270s015s016lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202270s015s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202270s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202270s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202270s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202270s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202270s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202270s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202270s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/02\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202270s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202270s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202270_janumet_xr_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202270Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/01\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202270s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"08\/12\/2019","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202270s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"02\/09\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202270s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/021995Orig1s042,022044s043,202270Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"08\/10\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202270s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"01\/18\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202270s015s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202270Orig1s015,s016ltr.pdf\"}]","notes":">"},{"actionDate":"01\/18\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202270s015s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202270Orig1s015,s016ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202270s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"04\/27\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202270s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"09\/19\/2014","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202270s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202270Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"10\/17\/2013","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/19\/2013","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/11\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202270s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202270Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"10\/18\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202270s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202270Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"04\/10\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-12
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.