Documents
Application Sponsors
| NDA 209805 | MERCK SHARP DOHME | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG;EQ 100MG BASE | 1 | STEGLUJAN | ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE |
| 002 | TABLET;ORAL | 15MG;EQ 100MG BASE | 1 | STEGLUJAN | ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2017-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2018-10-26 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-07-01 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-01-24 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2021-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-03-02 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2022-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2022-10-13 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 15 |
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"}]
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[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
)
)