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FDA Drug Application 019865 by COVIS PHARMA SARL

Application Number019865
Application Type New Drug Application
Sponsor ApplicantCOVIS PHARMA SARL
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
AP010/30/1992N       
AP04/13/1993SCM       
AP04/20/1994SCM       
AP09/6/1994SCM       
AP04/20/1994SLR       
AP07/26/1995SLR       
AP012/4/1995SCM       
AP08/23/1999SLR       
AP04/9/1999SCM       
AP010/1/2001SE84418010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_Approv.pdf 10/1/2001
AP010/1/2001SE84419010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_prntlbl.pdf 10/1/2001
AP010/1/2001SE84420010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865s10_Betapace.cfm 6/19/2002
AP07/7/2000SLR       
AP011/22/2000SCS       
AP07/26/2001SCS       
AP02/3/2011SLR27712019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s019lbl.pdf 2/4/2011
AP02/3/2011SLR27767019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019865s019ltr.pdf 2/9/2011
AP08/17/2011SLR29824020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019865s020ltr.pdf 8/18/2011
AP08/17/2011SLR29850020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s020lbl.pdf 8/24/2011
AP05/10/2016SLR45997021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019865s021lbl.pdf 5/11/2016
AP05/10/2016SLR46034021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019865Orig1s021ltr.pdf 5/17/2016




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