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FDA Drug Application 050527 by WARNER CHILCOTT

Application Number050527
Application Type New Drug Application
Sponsor ApplicantWARNER CHILCOTT
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
AP09/12/1980N       
AP011/4/1980SLR       
AP012/8/1980SCS       
AP03/31/1981SLR       
AP06/30/1981SLR       
AP08/7/1981SLR       
AP03/5/1987SCS       
AP010/27/1981SCM       
AP08/30/1991SE2       
AP09/12/1988SCF       
AP05/3/1989SLR       
AP01/20/1982SLR       
AP05/21/1982SCS       
AP010/15/1996SLR       
AP03/26/1999SCP       
AP05/3/2002SLR8932020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50512s044ltr.pdf 6/2/2004
AP05/3/2002SLR8933020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf 6/2/2004
AP012/16/2003SLR7290021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50512slr045,50527slr021,50528slr019ltr.pdf 12/19/2003
AP012/16/2003SLR7447021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50528slr019_duricef_lbl.pdf 12/29/2003
AP06/5/2007SLR16710022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050512s046, 050527s022, 050528s020ltr.pdf 6/7/2007
AP06/5/2007SLR16723022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf 6/7/2007




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