Documents
Application Sponsors
| NDA 209803 | MERCK SHARP DOHME | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 1 | STEGLATRO | ERTUGLIFLOZIN |
| 002 | TABLET;ORAL | 15MG | 1 | STEGLATRO | ERTUGLIFLOZIN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2017-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-01-24 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2021-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-10-13 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 6 |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 209803
[companyName] => MERCK SHARP DOHME
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/209803s002lbl.pdf#page=25"]
[products] => [{"drugName":"STEGLATRO","activeIngredients":"ERTUGLIFLOZIN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"STEGLATRO","activeIngredients":"ERTUGLIFLOZIN","strength":"15MG","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\\\/209803s002lbl.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\\\/209803s002lbl.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\\\/209803s001lbl.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\\\/209803s001lbl.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\\\/209803s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209803s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209803Orig1s000ltr.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\\\/209803s002lbl.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\\\/209803s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209803Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-01-24
)
)