Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 5MG;500MG | 1 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 5MG;1GM | 1 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
| 003 | TABLET, EXTENDED RELEASE;ORAL | 10MG;500MG | 1 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
| 004 | TABLET, EXTENDED RELEASE;ORAL | 10MG;1GM | 1 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
| 005 | TABLET, EXTENDED RELEASE;ORAL | 2.5MG;1GM | 1 | XIGDUO XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2014-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2016-01-12 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-12-04 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2016-08-17 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-03-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2017-01-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2017-07-28 | N/A |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2019-02-22 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2018-10-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2019-10-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | TA | 2019-08-12 | N/A |
| LABELING; Labeling | SUPPL | 13 | AP | 2020-01-24 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 14 | AP | 2020-02-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2022-02-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2022-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2022-10-13 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 15 |
CDER Filings
ASTRAZENECA AB
cder:Array
(
[0] => Array
(
[ApplNo] => 205649
[companyName] => ASTRAZENECA AB
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/205649s014lbl.pdf#page=52"]
[products] => [{"drugName":"XIGDUO XR","activeIngredients":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"5MG;500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XIGDUO XR","activeIngredients":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"5MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XIGDUO XR","activeIngredients":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"10MG;500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XIGDUO XR","activeIngredients":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"10MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"XIGDUO XR","activeIngredients":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/03\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205649s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205649s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2020","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205649s013lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2019","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205649s011lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2019","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205649s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205649s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2017","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)-New Strength","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205649s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"03\/01\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/17\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205649s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205649s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205649s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205649s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205649s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/29\/2014","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\\\/2014\\\/205649s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205649Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205649Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205649Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"02\/03\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205649s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"01\/24\/2020","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205649s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"08\/12\/2019","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205649Orig1s012ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2019","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205649s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"10\/26\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205649s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202293Orig1s017,205649Origs010,209091Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"02\/22\/2019","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205649s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/28\/2017","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)-New Strength","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205649s008lbl.pdf\"}]","notes":">"},{"actionDate":"01\/10\/2017","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/01\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205649Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"08\/17\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205649s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205649Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"06\/14\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205649s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205649Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"12\/04\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205649s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205649Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"01\/12\/2016","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/01\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-03
)
)