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FDA Drug Application 019880 by CORDEN PHARMA

Application Number019880
Application Type New Drug Application
Sponsor ApplicantCORDEN PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/3/1989N       
AP07/5/1991SE1       
AP06/12/1990SCS       
AP08/17/1990SCM       
AP02/23/1993SLR       
AP03/17/1995SLR       
AP01/6/1998SLR292009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19880S009_Paraplatin.pdf 1/6/1998
AP011/15/1999SLR       
AP02/14/2002SLR3115011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19880s11ltr.pdf 2/14/2002
AP04/30/2001SLR       
AP012/3/1999SLR       
AP09/7/2000SCM       
AP09/14/2000SCP       
AP04/30/2001SLR       
AP011/2/2000SCM       
AP03/21/2002SCP       
AP011/5/2010SLR26931020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019880s020ltr.pdf 11/12/2010




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