Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022200
Company: ASTRAZENECA AB
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 |
|---|---|---|---|---|---|
| 12/21/2022 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022200Orig1s034ltr.pdf | |
| 06/10/2022 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022200Orig1s033ltr.pdf | |
| 07/26/2022 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022200Orig1s032ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/21/2022 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s034lbl.pdf | |
| 07/26/2022 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s032lbl.pdf | |
| 06/10/2022 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s033lbl.pdf | |
| 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 |