Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021773
Company: ASTRAZENECA AB
Company: ASTRAZENECA AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BYETTA | EXENATIDE SYNTHETIC | 300MCG/1.2ML (250MCG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | Yes |
| BYETTA | EXENATIDE SYNTHETIC | 600MCG/2.4ML (250MCG/ML) | INJECTABLE;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 |
|---|---|---|---|---|---|---|---|
| 04/28/2005 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021773lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021773ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_ByettaTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/21/2022 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021773Orig1s048ltr.pdf | |
| 06/10/2022 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773Orig1s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021773Orig1s046, s047ltr.pdf | |
| 06/10/2022 | SUPPL-46 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773Orig1s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021773Orig1s046, s047ltr.pdf | |
| 11/04/2021 | SUPPL-45 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021773s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021773Orig1s045ltr.pdf | |
| 06/17/2021 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021773s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021773Orig1s044ltr.pdf | |
| 02/28/2020 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021773s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021773Orig1s043ltr.pdf | |
| 12/20/2018 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021773s041lbl.pdf | |
| 02/25/2015 | SUPPL-40 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021773s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021773Orig1s040ltr.pdf | |
| 08/12/2014 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/2014 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/2014 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/2014 | SUPPL-36 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021773s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021773Orig1s036ltr.pdf | |
| 04/23/2014 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/2011 | SUPPL-31 | REMS-Assessment |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s031ltr.pdf |
| 10/19/2011 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s029,s030ltr.pdf | |
| 10/19/2011 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s029,s030ltr.pdf | |
| 11/12/2010 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021773s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s028ltr.pdf | |
| 08/13/2010 | SUPPL-26 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s026ltr.pdf |
| 10/30/2009 | SUPPL-25 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf | |
| 10/30/2009 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf | |
| 10/30/2009 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf | |
| 10/30/2009 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf | |
| 01/11/2008 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021773s012ltr.pdf | |
| 10/30/2009 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf | |
| 06/17/2008 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021773s010ltr.pdf | |
| 10/30/2009 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf | |
| 02/10/2007 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021773s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021773s007ltr.pdf | |
| 12/22/2006 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s002, s006ltr.pdf | |
| 11/01/2006 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s005ltr.pdf | |
| 10/12/2006 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s004LTR.pdf | |
| 12/22/2006 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s002, s006ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/21/2022 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773s048lbl.pdf | |
| 06/10/2022 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773Orig1s046s047lbl.pdf | |
| 06/10/2022 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773Orig1s046s047lbl.pdf | |
| 11/04/2021 | SUPPL-45 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021773s045lbl.pdf | |
| 06/17/2021 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021773s044lbl.pdf | |
| 02/28/2020 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021773s043lbl.pdf | |
| 12/20/2018 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021773s041lbl.pdf | |
| 02/25/2015 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021773s040lbl.pdf | |
| 02/25/2015 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021773s040lbl.pdf | |
| 11/24/2014 | SUPPL-36 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021773s036lbl.pdf | |
| 10/19/2011 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf | |
| 10/19/2011 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf | |
| 11/12/2010 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021773s028lbl.pdf | |
| 10/30/2009 | SUPPL-25 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf | |
| 10/30/2009 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf | |
| 10/30/2009 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf | |
| 10/30/2009 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf | |
| 10/30/2009 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf | |
| 10/30/2009 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf | |
| 06/17/2008 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s010lbl.pdf | |
| 01/11/2008 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s012lbl.pdf | |
| 02/10/2007 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021773s007lbl.pdf | |
| 02/10/2007 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021773s007lbl.pdf | |
| 12/22/2006 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf | |
| 12/22/2006 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf | |
| 11/01/2006 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s005lbl.pdf | |
| 10/12/2006 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s004lbl.pdf | |
| 04/28/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021773lbl.pdf |