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
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

New Drug Application (NDA): 209210

Company: ASTRAZENECA AB

Medication Guide

Products on NDA 209210

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209210

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

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	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

Labels for NDA 209210

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	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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منبع : www.accessdata.fda.gov

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