NDA 210874

ASTRAZENECA AB

FDA Drug Application

Application #210874

Documents

• Label: 2019-05-03
• Medication Guide: 2019-05-03
• Letter: 2019-05-03
• Letter: 2019-07-02
• Label: 2019-07-08
• Medication Guide: 2019-07-08
• Review: 2020-01-27
• Label: 2020-01-27
• Medication Guide: 2020-01-27
• Letter: 2020-01-27

Application Sponsors

NDA 210874

ASTRAZENECA AB

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	2.5MG;1GM;EQ 2.5MG BASE	1	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM;EQ 2.5MG BASE	1	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM;EQ 5MG BASE	1	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM;EQ 5MG BASE	1	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2019-05-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-01-24	901 REQUIRED

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

CDER Filings

ASTRAZENECA AB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210874
            [companyName] => ASTRAZENECA AB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/210874s003lbl.pdf#page=47"]
            [products] => [{"drugName":"QTERNMET XR","activeIngredients":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","strength":"2.5MG;1GM;EQ 2.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"QTERNMET XR","activeIngredients":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","strength":"5MG;1GM;EQ 2.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"QTERNMET XR","activeIngredients":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","strength":"5MG;1GM;EQ 5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"QTERNMET XR","activeIngredients":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","strength":"10MG;1GM;EQ 5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210874s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210874s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210874s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/02\/2019","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\\\/2019\\\/210874s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210874Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/210874Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210874s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/01\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210874s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [actionDate] => 2020-01-24
        )

)