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FDA Drug Application 018031 by WYETH PHARMS INC

Application Number018031
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/15/1979N       
AP07/31/1979SCP       
AP012/10/1981SCS       
AP05/28/1980SCS       
AP03/27/1980SCE       
AP010/3/1980SCS       
AP01/27/1981SCS       
AP04/12/1982SCS       
AP09/19/1980SCF       
AP03/3/1982SCM       
AP01/26/1982SCM       
AP04/28/1982SLR       
AP06/9/1982SCS       
AP08/23/1982SCF       
AP08/11/1983SCS       
AP02/22/1985SCM       
AP02/8/1990SPD       
AP02/8/1990SE2       
AP07/24/1986SCS       
AP110/8/1986SCF       
AP21/20/1987SCP       
AP012/30/1986SCE       
AP05/25/1988SCP       
AP011/7/1988SLR       
AP07/10/1989SCS       
AP04/12/1989SCP       
AP08/9/1989SCP       
AP06/14/1994SCM       
AP011/7/1997SLR       
AP011/1/2001SLR       
AP05/3/2001SLR       
AP06/9/2004SLR9313032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18031slr032ltr.pdf 6/10/2004
AP012/29/2006SLR15586033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018031s033ltr.pdf 1/8/2007
AP02/21/2007SLR15951034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016418s077;018031s034ltr.pdf 3/6/2007
AP01/2/2008SLR18728035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018031s035lbl.pdf 1/8/2008
AP01/2/2008SLR18753035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018031s035ltr.pdf 1/9/2008
AP03/4/2010SLR24978036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018031s036lbl.pdf 3/5/2010
AP03/4/2010SLR24998036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018031s036ltr.pdf 3/8/2010
AP03/17/2011SLR28303037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf 3/21/2011
AP03/17/2011SLR28314037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018031s037,s038ltr.pdf 3/23/2011
AP03/17/2011SLR28315038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018031s037,s038ltr.pdf 3/23/2011
AP03/17/2011SLR28304038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018031s037s038lbl.pdf 3/21/2011




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