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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206321
Company: NOVO

Medication Guide

REMS

Products on NDA 206321

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SAXENDA	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206321

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2014	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206321Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206321Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206321Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/20/2023	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206321s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206321Orig1s016ltr.pdf
06/15/2022	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206321s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206321Orig1s015ltr.pdf
12/04/2020	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206321Orig1s012, s013, s014ltr.pdf
12/04/2020	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206321Orig1s012, s013, s014ltr.pdf
12/04/2020	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206321Orig1s012, s013, s014ltr.pdf
03/25/2020	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206321Orig1s011ltr.pdf
12/04/2018	SUPPL-9	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206321s009ltr.pdf
10/19/2018	SUPPL-7	Efficacy	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206321s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206321Orig1s007ltr.pdf
04/26/2017	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s004,s006ltr.pdf
05/22/2017	SUPPL-5	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s005ltredt.pdf
04/26/2017	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s004,s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/206321Orig1s004.pdf
09/22/2016	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206321s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s003ltr.pdf
02/01/2016	SUPPL-2	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s002ltr.pdf
03/27/2015	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206321s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206321Orig1s001ltr.pdf

Labels for NDA 206321

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/20/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206321s016lbl.pdf
06/15/2022	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206321s015lbl.pdf
12/04/2020	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf
12/04/2020	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf
12/04/2020	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf
12/04/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf
12/04/2020	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf
03/25/2020	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s011lbl.pdf
10/19/2018	SUPPL-7	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206321s007lbl.pdf
04/26/2017	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf
04/26/2017	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf
04/26/2017	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf
09/22/2016	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206321s003lbl.pdf
09/22/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206321s003lbl.pdf
03/27/2015	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206321s001lbl.pdf
12/23/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206321Orig1s000lbl.pdf

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