NDA 209806

MERCK SHARP DOHME

FDA Drug Application

Application #209806

Documents

• Label: 2017-12-19
• Letter: 2017-12-27
• Review: 2018-03-05
• Label: 2018-10-29
• Medication Guide: 2018-10-29
• Letter: 2018-10-30
• Label: 2020-01-27
• Medication Guide: 2020-01-27
• Letter: 2020-01-27
• Label: 2021-09-20
• Medication Guide: 2021-09-20
• Letter: 2021-09-21
• Letter: 2022-03-03
• Label: 2022-03-03
• Medication Guide: 2022-03-03
• Letter: 2022-10-14
• Label: 2022-10-17
• Medication Guide: 2022-10-17

Application Sponsors

NDA 209806

MERCK SHARP DOHME

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	2.5MG;500MG	1	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	2.5MG;1GM	1	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	7.5MG;500MG	1	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
004	TABLET;ORAL	7.5MG;1GM	1	SEGLUROMET	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2017-12-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-01-24	901 REQUIRED
EFFICACY; Efficacy	SUPPL	6	AP	2021-09-17	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-03-02	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-10-13	901 REQUIRED

Submissions Property Types

ORIG	1	Null	33
SUPPL	2	Null	6
SUPPL	6	Null	31
SUPPL	8	Null	15
SUPPL	9	Null	7

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209806
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/209806s002lbl.pdf#page=32"]
            [products] => [{"drugName":"SEGLUROMET","activeIngredients":"ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SEGLUROMET","activeIngredients":"ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SEGLUROMET","activeIngredients":"ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"7.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SEGLUROMET","activeIngredients":"ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"7.5MG;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209806s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209806s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209806s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209806s001lbl.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\\\/209806s000lbl.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\\\/209806s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209806Orig1s000ltr.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-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209806s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209803Orig1s002,209805Orig1s006,209806Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"10\/26\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209806s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209806Orig1s001Ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-01-24
        )

)