Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;SUBCUTANEOUS | 300MCG/1.2ML (250MCG/ML) | 1 | BYETTA | EXENATIDE SYNTHETIC |
| 002 | INJECTABLE;SUBCUTANEOUS | 600MCG/2.4ML (250MCG/ML) | 1 | BYETTA | EXENATIDE SYNTHETIC |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2005-04-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2006-12-22 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 2006-10-12 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2006-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2006-12-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2007-02-10 | N/A |
| LABELING; Labeling | SUPPL | 9 | AP | 2009-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2008-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2009-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2008-01-11 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2009-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2009-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2009-10-30 | STANDARD |
| REMS; REMS | SUPPL | 25 | AP | 2009-10-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 26 | AP | 2010-08-13 | UNKNOWN |
| LABELING; Labeling | SUPPL | 28 | AP | 2010-11-12 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2011-10-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2011-10-19 | STANDARD |
| REMS; REMS | SUPPL | 31 | AP | 2011-08-05 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2014-01-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2014-04-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2014-11-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2014-06-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2014-06-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2014-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2015-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 41 | AP | 2018-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2020-02-28 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2021-06-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 45 | AP | 2021-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2022-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2022-06-10 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 48 | AP | 2022-12-21 | STANDARD |
Submissions Property Types
| SUPPL | 9 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 6 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 41 | Null | 7 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 48 | Null | 6 |
CDER Filings
ASTRAZENECA AB
cder:Array
(
[0] => Array
(
[ApplNo] => 21773
[companyName] => ASTRAZENECA AB
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/021773s043lbl.pdf#page=35"]
[products] => [{"drugName":"BYETTA","activeIngredients":"EXENATIDE SYNTHETIC","strength":"300MCG\/1.2ML (250MCG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"BYETTA","activeIngredients":"EXENATIDE SYNTHETIC","strength":"600MCG\/2.4ML (250MCG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/28\/2020","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021773s043lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2018","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021773s041lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021773s040lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021773s040lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2014","submission":"SUPPL-36","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021773s036lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2011","submission":"SUPPL-30","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021773s029s030lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2011","submission":"SUPPL-29","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021773s029s030lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2010","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021773s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2009","submission":"SUPPL-25","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021773s9s11s18s22s25lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2009","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021773s9s11s18s22s25lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2009","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021773s9s11s18s22s25lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2009","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021773s9s11s18s22s25lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2009","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021773s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/10\/2007","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021773s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2006","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021773s022s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2006","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021773s022s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2006","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021773s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2006","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021773s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021773lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"BYETTA","submission":"EXENATIDE SYNTHETIC","actionType":"300MCG\/1.2ML (250MCG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BYETTA","submission":"EXENATIDE SYNTHETIC","actionType":"600MCG\/2.4ML (250MCG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-02-28
)
)