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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208743
Company: RADIUS

Medication Guide

Summary Review

Products on NDA 208743

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYMLOS	ABALOPARATIDE	3.12MG/1.56ML (2MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208743

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208743Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2023	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208743Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208743Orig1s015ltr.pdf
12/19/2022	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208743s013lbl.pdf
12/22/2021	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s010lbl.pdf
09/20/2021	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208743Orig1s009ltr.pdf
10/23/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208743s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208743Orig1s007ltr.pdf
06/20/2018	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s004ltr.pdf
10/17/2018	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s003ltr.pdf
02/05/2018	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s001ltr.pdf

Labels for NDA 208743

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2023	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208743Orig1s015lbl.pdf
12/21/2023	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208743Orig1s015lbl.pdf
12/21/2023	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208743Orig1s015lbl.pdf
12/19/2022	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208743s013lbl.pdf
12/22/2021	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s010lbl.pdf
09/20/2021	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s009lbl.pdf
10/23/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208743s007lbl.pdf
10/17/2018	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s003lbl.pdf
06/20/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s004lbl.pdf
02/05/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s001lbl.pdf
04/28/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf

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