BYDUREON BCISE 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
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BYDUREON BCISE از شرکت ASTRAZENECA AB

New Drug Application (NDA): 209210

Company: ASTRAZENECA AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BYDUREON BCISE EXENATIDE 2MG/0.85ML (2MG/0.85ML) SUSPENSION, EXTENDED RELEASE;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
10/20/2017 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209210s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209210Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209210Orig1s000TOC.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2021 SUPPL-17 Efficacy-New Indication

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209210s017lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209210Orig1s017ltr.pdf

12/02/2020 SUPPL-14 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s014lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209210Orig1s014ltr.pdf

02/28/2020 SUPPL-11 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209210Orig1s011ltr.pdf

07/25/2019 SUPPL-8 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf

07/25/2019 SUPPL-7 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf

07/25/2019 SUPPL-6 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf

07/25/2019 SUPPL-5 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf

07/25/2019 SUPPL-4 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf

07/25/2019 SUPPL-3 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf

07/25/2019 SUPPL-2 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf

02/15/2019 SUPPL-1 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s001lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/22/2021 SUPPL-17

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209210s017lbl.pdf
12/02/2020 SUPPL-14

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s014lbl.pdf
02/28/2020 SUPPL-11

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s011lbl.pdf
07/25/2019 SUPPL-8

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf
07/25/2019 SUPPL-7

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf
07/25/2019 SUPPL-6

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf
07/25/2019 SUPPL-5

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf
07/25/2019 SUPPL-4

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf
07/25/2019 SUPPL-3

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf
07/25/2019 SUPPL-2

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf
02/15/2019 SUPPL-1

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s001lbl.pdf
10/20/2017 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209210s000lbl.pdf
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