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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021817
Company: SANDOZ

Medication Guide

Summary Review

Products on NDA 021817

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RECLAST	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021817

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/2007	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021817lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021817s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021817TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2020	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021817s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021817Orig1s028ltr.pdf
07/07/2017	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021817s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021817Orig1s027ltr.pdf
05/24/2016	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
04/14/2016	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021817s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021817Orig1s022ltr.pdf
04/16/2015	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021817s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021817Orig1s021ltr.pdf
01/30/2015	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021817s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021817Orig1s020ltr.pdf
06/17/2014	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/13/2014	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/17/2013	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
04/19/2013	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021817s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021817Orig1s015ltr.pdf
07/23/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
08/15/2011	SUPPL-13	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s013ltr.pdf
08/31/2011	SUPPL-12	Labeling-Medication Guide, REMS	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021817Orig1s012.pdf
01/25/2011	SUPPL-9	REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s009ltr.pdf
03/08/2011	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s006ltr.pdf
05/29/2009	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021817s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021817s004ltr.pdf
03/13/2009	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021817s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021817s003ltr.pdf
12/19/2008	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021817s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021817s002ltr.pdf
06/03/2008	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021817s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021817s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021817se1-001_SUMR.pdf

Labels for NDA 021817

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2020	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021817s028lbl.pdf
07/07/2017	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021817s027lbl.pdf
04/14/2016	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021817s022lbl.pdf
04/16/2015	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021817s021lbl.pdf
01/30/2015	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021817s020lbl.pdf
04/19/2013	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021817s015lbl.pdf
08/31/2011	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s012lbl.pdf
08/31/2011	SUPPL-12	REMS	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s012lbl.pdf
03/08/2011	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s006lbl.pdf
01/25/2011	SUPPL-9	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s009lbl.pdf
05/29/2009	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021817s004lbl.pdf
03/13/2009	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021817s003lbl.pdf
12/19/2008	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021817s002lbl.pdf
06/03/2008	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021817s001lbl.pdf
04/16/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021817lbl.pdf

Therapeutic Equivalents for NDA 021817

RECLAST

INJECTABLE;INTRAVENOUS; EQ 5MG BASE/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RECLAST	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021817	SANDOZ
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	200918	AKORN
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204367	APOTEX
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	091363	DR REDDYS LABS LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204217	GLAND
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	209578	GLAND PHARMA LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202837	HOSPIRA INC
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202828	INFORLIFE
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213371	MEITHEAL
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203841	MYLAN LABS LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205254	MYLAN LABS LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202163	PII

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