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FDA Drug Application 050622 by LEDERLE

Application Number050622
Application Type New Drug Application
Sponsor ApplicantLEDERLE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/28/1989N       
AP05/31/1989SLR       
AP03/30/1990SCG       
AP06/25/1991SCM       
AP01/19/1993SLR       
AP012/5/1991SCM       
AP03/9/1992SLR       
AP09/10/1992SCM       
AP04/22/1993SCP       
AP03/9/1994SCS       
AP02/27/1998SLR       
AP02/6/2001SLR       
AP03/15/2001SCS       
AP03/29/2004SLR8216017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl.pdf 4/5/2004
AP03/29/2004SLR8296017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50621slr023,50622slr017ltr.pdf 4/7/2004
AP08/6/2002SCM       
AP08/20/2003SLR6577020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50621slr026,50622slr020ltr.pdf 8/28/2003
AP08/20/2003SLR6578020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_suprax_lbl.pdf 8/28/2003




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