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FDA Drug Application 050512 by WARNER CHILCOTT

Application Number050512
Application Type New Drug Application
Sponsor ApplicantWARNER CHILCOTT
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
AP02/17/1978N       
AP05/21/1982SCS       
AP07/8/1983SCP       
AP07/17/1982SCE       
AP09/12/1986SLR       
AP011/18/1987SCM       
AP08/30/1991SE2       
AP05/18/1989SLR       
AP09/12/1988SCS       
AP05/8/1978SLR       
AP05/8/1978SLR       
AP07/7/1978SCM       
AP07/21/1978SCP       
AP08/14/1978SCE       
AP02/26/1979SLR       
AP05/5/1980SCS       
AP011/30/1979SCS       
AP04/26/1979SCP       
AP010/25/1979SLR       
AP012/28/1979SLR       
AP01/24/1980SCE       
AP01/21/1980SCE       
AP01/31/1980SLR       
AP02/22/1980SLR       
AP04/3/1981SLR       
AP04/21/1981SLR       
AP08/18/1981SCP       
AP08/24/1981SCP       
AP010/27/1981SCM       
AP011/2/1981SCP       
AP011/2/1981SCS       
AP01/20/1982SLR       
AP010/15/1996SLR       
AP05/3/2002SLR8930044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50512s044ltr.pdf 6/2/2004
AP05/3/2002SLR8931044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50512s44lbl.pdf 6/2/2004
AP012/16/2003SLR7289045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50512slr045,50527slr021,50528slr019ltr.pdf 12/19/2003
AP012/16/2003SLR7446045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50512slr045,50527slr021,50528slr019_duricef_lbl.pdf 12/29/2003
AP06/5/2007SLR16711046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050512s046, 050527s022, 050528s020ltr.pdf 6/7/2007
AP06/5/2007SLR16722046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050512s046,050527s022,050528s020lbl.pdf 6/7/2007




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