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Drugs@FDA: FDA-Approved Drugs

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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 SYNTHETIC	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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2024	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209210s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209210Orig1s023ltr.pdf
12/21/2022	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209210Orig1s022ltr.pdf
06/10/2022	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209210Orig1s021ltr.pdf
07/26/2022	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209210Orig1s019ltr.pdf
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	Note	Url
03/06/2024	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209210s023lbl.pdf
12/21/2022	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s022lbl.pdf
07/26/2022	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s019lbl.pdf
06/10/2022	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s021lbl.pdf
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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