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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202344
Company: RADIUS

Medication Guide

Medication Guide

Summary Review

Products on NDA 202344

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BINOSTO	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET, EFFERVESCENT;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202344

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/2012	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202344s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202344s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202344_binosto_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202344Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2020	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202344s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202344Orig1s015ltr.pdf
06/08/2020	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202344s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202344Orig1s013ltr.pdf
12/30/2016	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202344s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202344Orig1s011ltr.pdf
03/22/2016	SUPPL-10	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202344Orig1s010ltr.pdf
01/26/2016	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/08/2015	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202344Orig1s008ltr.pdf
02/26/2015	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202344Orig1s007ltr.pdf
12/23/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/17/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/02/2013	SUPPL-2	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202344s002lbl.pdf
04/19/2013	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202344s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202344Orig1s001ltr.pdf

Labels for NDA 202344

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2020	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202344s015lbl.pdf
06/08/2020	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202344s013lbl.pdf
06/08/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202344s013lbl.pdf
12/30/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202344s011lbl.pdf
04/08/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s008lbl.pdf
02/26/2015	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s007lbl.pdf
08/02/2013	SUPPL-2	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202344s002lbl.pdf
04/19/2013	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202344s001lbl.pdf
04/19/2013	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202344s001lbl.pdf
04/19/2013	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202344s001lbl.pdf
03/12/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202344s000lbl.pdf

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