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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/28/2025 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022200s036lbl.pdf | |
| 11/01/2024 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022200s035lbl.pdf | |
| 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 |