Drugs@FDA: FDA Approved Drug Products

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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 Prescription None Yes Yes
BYDUREON PEN EXENATIDE SYNTHETIC 2MG FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS Prescription None Yes Yes
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
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
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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