Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021223
Company: NOVARTIS
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| ZOMETA | ZOLEDRONIC ACID | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
| ZOMETA | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
| ZOMETA | ZOLEDRONIC ACID | EQ 4MG BASE/100ML | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
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 |