BYETTA از شرکت ASTRAZENECA AB

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

BYETTA از شرکت ASTRAZENECA AB

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
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-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
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-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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