Back to FDA Applications sponsored by NOVARTIS

FDA Drug Application 021223 by NOVARTIS

Application Number021223
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/20/2001N2174000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21223ltr.pdf 8/20/2001
AP08/20/2001N2175000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21223lbl.pdf 8/20/2001
AP08/20/2001N2176000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-223_Zometa.cfm 8/20/2001
AP08/20/2001N7237000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 12/12/2003
AP02/12/2002SCM       
AP05/13/2002SCM       
AP02/22/2002SLR2178003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21223s3ltr.pdf 2/22/2002
AP02/22/2002SLR2179003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf 2/22/2002
AP02/22/2002SLR2180003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-386_Zometa.cfm 2/22/2002
AP03/7/2003SCF4480004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21223scf004_zometa_lbl.pdf 3/26/2003
AP03/7/2003SCF4481004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21223scf004ltr.pdf 3/26/2003
AP03/7/2003SCF20406004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021223_s004_ZOMETA.pdf 8/1/2008
AP02/27/2004SLR7786006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21223slr006,21386se8-001ltr.pdf 3/2/2004
AP02/27/2004SLR8037006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021223s006lbl.pdf 3/25/2004
AP03/24/2004SLR8116008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21223slr008ltr.pdf 3/28/2004
AP03/24/2004SLR8232008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21223slr008_zometa_lbl.pdf 4/5/2004
AP01/31/2005SLR11075009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021223s009,010ltr.pdf 2/3/2005
AP01/31/2005SLR11078009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s009,010lbl.pdf 2/3/2005
AP01/31/2005SLR11076010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021223s009,010ltr.pdf 2/3/2005
AP01/31/2005SLR11079010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s009,010lbl.pdf 2/3/2005
AP010/11/2005SLR12870011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021223s011ltr.pdf 10/14/2005
AP010/11/2005SLR12880011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021223s011lbl.pdf 10/14/2005
AP05/25/2006SLR14178012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021223s012lbl.pdf 5/26/2006
AP05/25/2006SLR14186012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021223s012LTRpdf.pdf 5/26/2006
AP011/2/2007SLR18338014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021223s014lbl.pdf 11/7/2007
AP011/2/2007SLR18357014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021223s014, s015ltr.pdf 11/8/2007
AP011/2/2007S18358015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021223s014, s015ltr.pdf 11/8/2007
AP03/20/2008SE519497016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021223s016ltr.pdf 3/21/2008
AP03/20/2008SE519510016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021223s016lbl.pdf 3/24/2008
AP011/9/2009SLR23924018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021223s018lbl.pdf 11/17/2009
AP011/9/2009SLR24604018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021223s018ltr.pdf 1/25/2010
AP03/14/2012SLR32128022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021223Orig1s022ltr.pdf 3/16/2012
AP03/14/2012SLR32143022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021223s022lbl.pdf 3/16/2012
AP011/9/2012SLR34371023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021223Orig1s023ltr_replacement.pdf 11/14/2012
AP011/9/2012SLR34392023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021223s023lbl.pdf 11/15/2012
AP03/6/2013SCM       
AP09/27/2013SLR37267027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021223Orig1s027ltr.pdf 10/1/2013
AP09/27/2013SLR37299027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021223s027lbl.pdf 10/1/2013
AP04/7/2014SLR38992028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021223Orig1s028ltr_replacement.pdf 4/8/2014
AP04/7/2014SLR39013028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021223s028lbl.pdf 4/8/2014
AP06/17/2014SCM       
AP01/5/2015SLR41511031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021223Orig1s031ltr.pdf 1/7/2015
AP01/5/2015SLR41543031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021223s031lbl.pdf 1/8/2015
AP06/9/2015SLR43035032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021223Orig1s032ltr.pdf 6/10/2015
AP06/9/2015SLR43044032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021223s032lbl.pdf 6/11/2015
AP04/22/2016SCM       
AP03/29/2016SLR45562034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021223s034lbl.pdf 3/31/2016
AP03/29/2016SLR45574034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021223Orig1s034ltr.pdf 4/4/2016




Back to FDA Applications sponsored by NOVARTIS