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FDA Drug Application 020981 by NOVARTIS PHARMS CORP

Application Number020981
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/12/2007N18234000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020981lbl.pdf 10/12/2007
AP010/12/2007N18290000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020981s000ltr.pdf 10/22/2007
AP010/12/2007N21643000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020981_hycamtin_toc.cfm 1/15/2009
AP010/12/2007N21644000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020981s000_SumR.pdf 1/15/2009
AP06/30/2010SLR25896002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020981s002ltr.pdf 7/2/2010
AP06/30/2010SLR25922002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020981s002lbl.pdf 7/6/2010
AP010/7/2011SLR30251005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020981s005ltr.pdf 10/12/2011
AP010/7/2011SLR30259005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020981s005lbl.pdf 10/12/2011
AP06/18/2014SLR39587006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020981Orig1s006ltr.pdf 6/19/2014
AP06/18/2014SLR39626006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020981s006lbl.pdf 6/23/2014




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