Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021223
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOMETA ZOLEDRONIC ACID EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRAVENOUS Discontinued None Yes No
ZOMETA ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
ZOMETA ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS 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
08/20/2001 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21223lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21223ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-223_Zometa.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/14/2018 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021223s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021223Orig1s041ltr.pdf
01/26/2017 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/15/2016 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

12/28/2016 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021223s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021223Orig1s035ltr.pdf
03/29/2016 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021223s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021223Orig1s034ltr.pdf
04/22/2016 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/09/2015 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021223s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021223Orig1s032ltr.pdf
01/05/2015 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021223s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021223Orig1s031ltr.pdf
06/17/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/07/2014 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021223s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021223Orig1s028ltr_replacement.pdf
09/27/2013 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021223s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021223Orig1s027ltr.pdf
03/06/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/09/2012 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021223s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021223Orig1s023ltr_replacement.pdf
03/14/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021223s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021223Orig1s022ltr.pdf
11/09/2009 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021223s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021223s018ltr.pdf
03/20/2008 SUPPL-16 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021223s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021223s016ltr.pdf
11/02/2007 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021223s014, s015ltr.pdf
11/02/2007 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021223s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021223s014, s015ltr.pdf
05/25/2006 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021223s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021223s012LTRpdf.pdf
10/11/2005 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021223s011ltr.pdf
01/31/2005 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s009,010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021223s009,010ltr.pdf
01/31/2005 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s009,010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021223s009,010ltr.pdf
03/24/2004 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21223slr008_zometa_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21223slr008ltr.pdf
02/27/2004 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021223s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21223slr006,21386se8-001ltr.pdf
03/07/2003 SUPPL-4 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21223scf004_zometa_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21223scf004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021223_s004_ZOMETA.pdf
02/22/2002 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21223s3ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-386_Zometa.cfm
05/13/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/12/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/14/2018 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021223s041lbl.pdf
12/28/2016 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021223s035lbl.pdf
03/29/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021223s034lbl.pdf
06/09/2015 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021223s032lbl.pdf
01/05/2015 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021223s031lbl.pdf
04/07/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021223s028lbl.pdf
09/27/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021223s027lbl.pdf
11/09/2012 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021223s023lbl.pdf
03/14/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021223s022lbl.pdf
11/09/2009 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021223s018lbl.pdf
03/20/2008 SUPPL-16 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021223s016lbl.pdf
11/02/2007 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021223s014lbl.pdf
05/25/2006 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021223s012lbl.pdf
10/11/2005 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s011lbl.pdf
01/31/2005 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s009,010lbl.pdf
01/31/2005 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s009,010lbl.pdf
03/24/2004 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21223slr008_zometa_lbl.pdf
02/27/2004 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021223s006lbl.pdf
03/07/2003 SUPPL-4 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21223scf004_zometa_lbl.pdf
02/22/2002 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf
08/20/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21223lbl.pdf

ZOMETA

INJECTABLE;INTRAVENOUS; EQ 4MG BASE/5ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 205279 ACCORD HLTHCARE
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 202548 AKORN INC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 207751 AUROBINDO PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 207341 BPI LABS LLC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 091170 BRECKENRIDGE PHARM
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 202571 BRECKENRIDGE PHARM
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 091186 DR REDDYS LABS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 201783 EMCURE PHARMS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 091516 FRESENIUS KABI USA
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 202930 GLAND PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 202182 HIKMA FARMACEUTICA
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 090621 HOSPIRA INC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 202650 MYLAN LABS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 091493 SAGENT PHARMS
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 208513 SHILPA MEDICARE LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription No AP 202923 USV
ZOMETA ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;INTRAVENOUS Prescription Yes AP 021223 NOVARTIS

INJECTABLE;INTRAVENOUS; EQ 4MG BASE/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZOLEDRONIC ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 205749 GLAND PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 210174 CIPLA
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 204344 DR REDDYS LABS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 203231 INFORLIFE
ZOMETA ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription Yes AP 021223 NOVARTIS

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