Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 10MG;EQ 5MG BASE | 1 | QTERN | DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE |
| 002 | TABLET;ORAL | 5MG;EQ 5MG BASE | 1 | QTERN | DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2017-02-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2019-05-02 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-07-01 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-01-24 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-10-13 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
CDER Filings
ASTRAZENECA AB
cder:Array
(
[0] => Array
(
[ApplNo] => 209091
[companyName] => ASTRAZENECA AB
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/209091s005lbl.pdf#page=37"]
[products] => [{"drugName":"QTERN","activeIngredients":"DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE","strength":"10MG;EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"QTERN","activeIngredients":"DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE","strength":"5MG;EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209091s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209091s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209091s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209091s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209091s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"02\/27\/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\\\/209091s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209091Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209091Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209091s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/01\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209091s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"10\/26\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209091s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202293Orig1s017,205649Origs010,209091Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"05\/02\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209091s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209091Orig1s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-01-24
)
)