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FDA Drug Application 021386 by NOVARTIS

Application Number021386
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/22/2002N8039000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 3/25/2004
AP02/22/2002N9666000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21223s3ltr.pdf 7/1/2004
AP02/22/2002N9667000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf 7/1/2004
AP02/22/2002N9668000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-386_Zometa.cfm 7/1/2004
AP02/27/2004SE87787001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21223slr006,21386se8-001ltr.pdf 3/2/2004
AP02/27/2004SE88038001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021223s006lbl.pdf 3/25/2004
AP02/4/2011SLR27773004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021386s004lbl.pdf 2/9/2011
AP02/4/2011SLR27796004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021386s004ltr.pdf 2/9/2011




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