Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 2MG/VIAL | 1 | BYDUREON | EXENATIDE SYNTHETIC |
| 002 | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 2MG | 1 | BYDUREON PEN | EXENATIDE SYNTHETIC |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2012-01-27 | STANDARD test |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2013-06-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2013-02-27 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-02-28 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2014-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2014-03-24 | STANDARD |
| REMS; REMS | SUPPL | 10 | AP | 2015-04-29 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2015-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2014-05-22 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 13 | AP | 2014-05-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2015-03-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2015-09-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2015-09-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2015-09-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2015-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2015-03-09 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 20 | AP | 2015-09-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2015-12-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2015-12-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2016-01-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2016-06-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2017-10-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2018-04-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 2019-02-15 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2020-02-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 31 | AP | 2021-07-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 32 | AP | 2022-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2022-06-10 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 34 | AP | 2022-12-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 30 | Null | 15 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 34 | Null | 6 |
CDER Filings
ASTRAZENECA AB
cder:Array
(
[0] => Array
(
[ApplNo] => 22200
[companyName] => ASTRAZENECA AB
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/022200s026lbl.pdf#page=31"]
[products] => [{"drugName":"BYDUREON","activeIngredients":"EXENATIDE SYNTHETIC","strength":"2MG\/VIAL","dosageForm":"FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"BYDUREON PEN","activeIngredients":"EXENATIDE SYNTHETIC","strength":"2MG","dosageForm":"FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/28\/2020","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022200s030lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2019","submission":"SUPPL-28","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022200s028lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2018","submission":"SUPPL-26","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022200s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2017","submission":"SUPPL-25","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022200s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2015","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022200s015s016s017s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2015","submission":"SUPPL-17","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022200s015s016s017s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2015","submission":"SUPPL-16","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022200s015s016s017s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2015","submission":"SUPPL-15","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022200s015s016s017s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022200s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022200s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2015","submission":"SUPPL-14","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022200s014lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/22\/2014","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022200s012s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022200s012s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2014","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022200s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022200Orig1s000lbledt.pdf\"}]","notes":"test"}]
[originalApprovals] => [{"actionDate":"BYDUREON","submission":"EXENATIDE SYNTHETIC","actionType":"2MG\/VIAL","submissionClassification":"FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BYDUREON PEN","submission":"EXENATIDE SYNTHETIC","actionType":"2MG","submissionClassification":"FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-02-28
)
)