Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021773
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
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-Package Insert, Labeling-Container/Carton Labels 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021773s040lbl.pdf
02/25/2015 SUPPL-40 Labeling-Container/Carton Labels 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

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