MERCK SHARP DOHME FDA Approval NDA 209805

NDA 209805

MERCK SHARP DOHME

FDA Drug Application

Application #209805

Documents

Label2017-12-20
Letter2017-12-27
Review2018-03-05
Label2018-03-08
Medication Guide2018-03-08
Letter2018-03-15
Label2018-10-29
Medication Guide2018-10-29
Letter2018-10-30
Letter2019-07-02
Label2019-07-12
Medication Guide2019-07-12
Label2020-01-27
Medication Guide2020-01-27
Letter2020-01-27
Label2021-09-20
Medication Guide2021-09-20
Letter2021-09-21
Letter2022-03-03
Label2022-03-03
Medication Guide2022-03-03
Letter2022-06-22
Label2022-06-24
Medication Guide2022-06-24
Letter2022-10-14
Label2022-10-17
Medication Guide2022-10-17

Application Sponsors

NDA 209805MERCK SHARP DOHME

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG;EQ 100MG BASE1STEGLUJANERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
002TABLET;ORAL15MG;EQ 100MG BASE1STEGLUJANERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2017-12-19STANDARD
LABELING; LabelingSUPPL4AP2018-10-26901 REQUIRED
LABELING; LabelingSUPPL5AP2019-07-01901 REQUIRED
LABELING; LabelingSUPPL6AP2020-01-24901 REQUIRED
EFFICACY; EfficacySUPPL8AP2021-09-17STANDARD
LABELING; LabelingSUPPL10AP2022-03-02STANDARD
LABELING; LabelingSUPPL11AP2022-06-21STANDARD
LABELING; LabelingSUPPL12AP2022-10-13901 REQUIRED

Submissions Property Types

ORIG1Null40
SUPPL4Null7
SUPPL5Null7
SUPPL6Null15
SUPPL8Null7
SUPPL10Null15
SUPPL11Null6
SUPPL12Null15

CDER Filings

MERCK SHARP DOHME
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209805
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/209805s006lbl.pdf#page=32"]
            [products] => [{"drugName":"STEGLUJAN","activeIngredients":"ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE","strength":"5MG;EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"STEGLUJAN","activeIngredients":"ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE","strength":"15MG;EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209805s006lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209805s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209805s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209805s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209805s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209805s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209805s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209805s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209805Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209803,209805,209806Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209805s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209803Orig1s002,209805Orig1s006,209806Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"07\/01\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209805s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209805Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"10\/26\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209805s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209805Orig1s004Ltr.pdf\"}]","notes":">"},{"actionDate":"03\/06\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209805s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209805Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-01-24
        )

)

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