Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021817
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RECLAST ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription AP Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

RECLAST

INJECTABLE;IV (INFUSION); 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;IV (INFUSION) Prescription Yes AP 021817 NOVARTIS
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 200918 AKORN
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 204367 APOTEX INC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 209125 AUROBINDO PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 202163 BRECKENRIDGE PHARM
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 091363 DR REDDYS LABS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 201801 EMCURE PHARMS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 204217 GLAND PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 202837 HOSPIRA INC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 202828 INFORLIFE
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 203841 MYLAN LABS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;IV (INFUSION) Prescription No AP 205254 MYLAN LABS LTD

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