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FDA Drug Application 019500 by NOVARTIS

Application Number019500
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
AP012/15/1986N       
AP09/22/1988SCS       
AP03/30/1989SLR       
AP07/20/1995SCS       
AP09/5/1995SCF       
AP09/12/1995SCM       
AP01/16/1998SCS       
AP07/13/2000SCM       
AP06/20/2001SCM       
AP04/12/2002SCM       
AP06/11/2003SLR5953010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19500slr010ltr.pdf 6/22/2003
AP06/11/2003SLR6000010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19500slr010_lamprene_lbl.pdf 6/22/2003
AP07/8/2016SLR46505013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019500Orig1s013ltr.pdf 7/12/2016




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