BYDUREON از شرکت ASTRAZENECA AB

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

BYDUREON از شرکت ASTRAZENECA AB

New Drug Application (NDA): 022200

Company: ASTRAZENECA AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BYDUREON EXENATIDE SYNTHETIC 2MG/VIAL FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS Discontinued

None

Yes No
BYDUREON PEN EXENATIDE SYNTHETIC 2MG FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS Discontinued

None

Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/27/2012 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

test

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200Orig1s000lbledt.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022200Orig1s000_corrected_ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumRedt.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2021 SUPPL-31 Efficacy-New Indication

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022200s031lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022200Orig1s031ltr.pdf

02/28/2020 SUPPL-30 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022200s030lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022200Orig1s030ltr.pdf

02/15/2019 SUPPL-28 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022200s028lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022200Orig1s028ltr.pdf

04/02/2018 SUPPL-26 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022200s026ltr.pdf

10/20/2017 SUPPL-25 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022200s025lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022200Orig1s025ltr.pdf

06/10/2016 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/11/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/23/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/31/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/18/2015 SUPPL-20 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s020lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s020ltr.pdf

03/09/2015 SUPPL-19 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s019ltr.pdf

09/24/2015 SUPPL-18 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf

09/24/2015 SUPPL-17 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf

09/24/2015 SUPPL-16 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf

09/24/2015 SUPPL-15 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf

03/05/2015 SUPPL-14 Manufacturing (CMC)

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s014lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s014ltr.pdf

05/22/2014 SUPPL-13 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013ltr.pdf

05/22/2014 SUPPL-12 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013ltr.pdf

08/14/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/29/2015 SUPPL-10 REMS-Modified, REMS-Assessment

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s010ltr.pdf

03/24/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/28/2014 SUPPL-8 Labeling-Package Insert

Label (PDF)

Letter (PDF)

Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s008ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022200Orig1s008.pdf

02/28/2014 SUPPL-7 Labeling-Proprietary Name Change

Label is not available on this site.

02/27/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/12/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/22/2021 SUPPL-31

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022200s031lbl.pdf
02/28/2020 SUPPL-30

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022200s030lbl.pdf
02/15/2019 SUPPL-28

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022200s028lbl.pdf
04/02/2018 SUPPL-26

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf
10/20/2017 SUPPL-25

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022200s025lbl.pdf
09/24/2015 SUPPL-18

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf
09/24/2015 SUPPL-17

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf
09/24/2015 SUPPL-16

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf
09/24/2015 SUPPL-15

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf
09/18/2015 SUPPL-20

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s020lbl.pdf
03/09/2015 SUPPL-19

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s019lbl.pdf
03/05/2015 SUPPL-14

Manufacturing (CMC)

Label (PDF)

This supplement type does not usually require new labeling.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s014lbl.pdf
05/22/2014 SUPPL-13

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf
05/22/2014 SUPPL-12

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf
02/28/2014 SUPPL-8

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s008lbl.pdf
01/27/2012 ORIG-1 Approval

Label (PDF)

test

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200Orig1s000lbledt.pdf
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