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FDA Drug Application 018768 by CORDEN PHARMA

Application Number018768
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
AP011/10/1983N       
AP08/21/1984SCS       
AP03/6/1985SLR       
AP03/6/1985SLR       
AP03/6/1985SLR       
AP03/6/1985SLR       
AP03/12/1985SCS       
AP09/4/1986SE1       
AP011/6/1986SCM       
AP08/26/1986SLR       
AP06/30/1986SCM       
AP010/29/1986SCM       
AP012/22/1986SLR       
AP03/19/1987SCM       
AP04/28/1988SCM       
AP05/20/1987SLR       
AP01/25/1988SLR       
AP02/11/1988SCS       
AP04/10/1989SCS       
AP04/4/1990SCM       
AP09/4/1990SCS       
AP011/1/1991SLR       
AP011/1/1991SLR       
AP05/17/1995SCS       
AP08/24/1993SCS       
AP07/23/1993SLR       
AP012/20/1993SCM       
AP08/30/1993SCM       
AP06/27/1995SCS       
AP08/8/1995SCS       
AP012/11/1995SCS       
AP012/15/1998SCS       
AP04/2/1999SLR1103041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18768S041_VePesid.pdf 4/2/1999
AP02/2/2000SCF       
AP011/5/2002SLR2264045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18768slr045,19557slr028ltr.pdf 11/5/2002
AP011/5/2002SLR17011045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018768_S045_VEPESIDE.pdf 7/6/2007
AP011/5/2002SLR33360045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf 8/3/2012
AP010/25/2000SCM       




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