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FDA Drug Application 050621 by LEDERLE

Application Number050621
Application Type New Drug Application
Sponsor ApplicantLEDERLE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/28/1989N       
AP05/31/1989SLR       
AP06/25/1991SCM       
AP04/18/1990SCG       
AP03/9/1992SCP       
AP010/31/1990SCG       
AP07/12/1990SCG       
AP01/19/1993SLR       
AP02/27/1992SCP       
AP02/5/1993SE1       
AP02/28/1992SCP       
AP09/10/1992SCM       
AP011/13/1992SCM       
AP03/10/1994SCS       
AP02/27/1998SLR       
AP03/29/2004SLR8215023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl.pdf 4/5/2004
AP03/29/2004SLR8295023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50621slr023,50622slr017ltr.pdf 4/7/2004
AP08/16/2002SCM       
AP08/20/2003SLR6575026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50621slr026,50622slr020ltr.pdf 8/28/2003
AP08/20/2003SLR6576026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_suprax_lbl.pdf 8/28/2003




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