NDA 209210

ASTRAZENECA AB

FDA Drug Application

Application #209210

Documents

• Label: 2017-10-24
• Letter: 2017-11-27
• Review: 2018-10-10
• Label: 2019-02-20
• Letter: 2019-02-21
• Letter: 2019-07-26
• Letter: 2019-07-26
• Letter: 2019-07-26
• Letter: 2019-07-26
• Letter: 2019-07-26
• Letter: 2019-07-26
• Letter: 2019-07-26
• Label: 2019-07-30
• Label: 2019-07-30
• Label: 2019-07-30
• Label: 2019-07-30
• Label: 2019-07-30
• Label: 2019-07-30
• Label: 2019-07-30
• Medication Guide: 2019-07-30
• Label: 2020-03-02
• Medication Guide: 2020-03-02
• Letter: 2020-03-03
• Medication Guide: 2020-12-02
• Label: 2020-12-02
• Letter: 2020-12-03
• Label: 2021-07-23
• Letter: 2021-07-26
• Letter: 2022-06-14
• Label: 2022-06-15
• Medication Guide: 2022-06-15
• Letter: 2022-07-27
• Label: 2022-07-27
• Medication Guide: 2022-07-27
• Letter: 2022-12-22
• Label: 2022-12-23
• Medication Guide: 2022-12-23

Application Sponsors

NDA 209210

ASTRAZENECA AB

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

2MG/0.85ML (2MG/0.85ML)

1

BYDUREON BCISE

EXENATIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2017-10-20	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2019-07-25	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2019-07-25	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2019-07-25	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2019-07-25	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2019-07-25	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2019-07-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-07-25	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-02-28	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-12-02	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2021-07-22	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2022-07-26	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-06-10	901 REQUIRED
LABELING; Labeling	SUPPL	22	AP	2022-12-21	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	31
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	7
SUPPL	14	Null	6
SUPPL	17	Null	6
SUPPL	19	Null	6
SUPPL	21	Null	7
SUPPL	22	Null	6

CDER Filings

ASTRAZENECA AB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209210
            [companyName] => ASTRAZENECA AB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/209210s011lbl.pdf#page=33"]
            [products] => [{"drugName":"BYDUREON BCISE","activeIngredients":"EXENATIDE","strength":"2MG\/0.85ML (2MG\/0.85ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/28\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209210s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2019","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2019","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209210s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209210s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209210Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209210Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/28\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209210s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209210Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2019","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2019","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s002s003s004s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"02\/15\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209210s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209210Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-02-28
        )

)