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FDA Drug Application 016418 by WYETH PHARMS INC

Application Number016418
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/13/1967N       
AP02/18/1975SLR       
AP08/21/1978SLR       
AP09/21/1976SCS       
AP011/3/1977SCS       
AP012/8/1977SCP       
AP03/7/1979SLR       
AP01/17/1979SES       
AP04/24/1978SCP       
AP04/24/1978SCS       
AP02/14/1978SCP       
AP012/12/1978SLR       
AP08/3/1978SCP       
AP02/12/1979SCS       
AP05/3/1979SCF       
AP03/21/1979SCS       
AP03/7/1979SCS       
AP010/31/1986SE1       
AP03/24/1980SCF       
AP03/24/1980SCP       
AP09/16/1980SCS       
AP09/19/1980SCS       
AP03/21/1983SCM       
AP01/26/1982SLR       
AP010/31/1986SE1       
AP010/15/1981SCM       
AP02/8/1982SCS       
AP09/30/1983SES       
AP010/18/1982SES       
AP010/18/1982SLR       
AP010/31/1986SE1       
AP011/12/1982SCF       
AP01/7/1983SCS       
AP01/21/1983SLR       
AP06/18/1985SCS       
AP01/12/1984SCS       
AP02/22/1985SCM       
AP05/21/1984SCF       
AP02/25/1985SCP       
AP012/20/1984SCS       
AP02/28/1985SCP       
AP010/9/1985SCE       
AP01/20/1987SCS       
AP05/25/1988SCP       
AP03/30/1989SCE       
AP02/15/1990SLR       
AP011/7/1997SLR       
AP08/22/1999SLR       
AP02/6/2002SLR       
AP08/18/2004SLR10062073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16418s073ltr.pdf 8/25/2004
AP08/18/2004SLR10066073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16418s073lbl.pdf 8/25/2004
AP012/29/2006SLR15587076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016418s076ltr.pdf 1/8/2007
AP02/21/2007SLR15950077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016418s077;018031s034ltr.pdf 3/6/2007
AP09/6/2007SLR17777078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016418s078lbl.pdf 9/7/2007
AP09/6/2007SLR17809078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016418s078_ltr.pdf 9/7/2007
AP05/6/2008SLR19793079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016418s079ltr.pdf 5/9/2008
AP03/17/2011SLR28307080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf 3/22/2011
AP03/17/2011SLR28312080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016418s080,016762s017,017683s008ltr.pdf 3/23/2011




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