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FDA Drug Application 050528 by WARNER CHILCOTT

Application Number050528
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
AP08/6/1980N       
AP07/8/1983SCP       
AP09/12/1986SLR       
AP011/18/1987SCM       
AP08/30/1991SE2       
AP09/12/1988SCS       
AP02/28/1990SLR       
AP010/15/1996SLR       
AP05/3/2002SLR8934018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50512s044ltr.pdf 6/2/2004
AP05/3/2002SLR8935018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf 6/2/2004
AP012/16/2003SLR7291019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50512slr045,50527slr021,50528slr019ltr.pdf 12/19/2003
AP012/16/2003SLR7448019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50528slr019_duricef_lbl.pdf 12/29/2003
AP06/5/2007SLR16709020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050512s046, 050527s022, 050528s020ltr.pdf 6/7/2007
AP06/5/2007SLR16724020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf 6/7/2007




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