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FDA Drug Application 050545 by WYETH PHARMS INC

Application Number050545
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
AP012/29/1981N       
AP08/6/1984SE1       
AP03/1/1983SCS       
AP03/18/1983SCS       
AP07/5/1983SCP       
AP08/6/1984SE1       
AP08/1/1984SCM       
AP08/23/1984SLR       
AP01/30/1985SCS       
AP05/31/1985SCS       
AP06/19/1985SLR       
AP06/3/1985SCS       
AP09/30/1985SCP       
AP08/15/1986SLR       
AP03/30/1989SCE       
AP04/8/1987SLR       
AP05/27/1987SCS       
AP010/6/1987SCS       
AP07/22/1987SCF       
AP09/25/1987SLR       
AP012/22/1987SLR       
AP05/3/1988SCF       
AP05/13/1988SLR       
AP010/4/1989SCS       
AP09/20/1991SCS       
AP05/22/2003SLR5851031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr033,50545slr037ltr.pdf 6/8/2003
AP05/22/2003SLR5850033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr033,50545slr037ltr.pdf 6/8/2003
AP03/11/1999SCM       
AP07/13/1998SCM       
AP011/22/2000SCM       
AP05/22/2003SLR5849037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50545slr037,50545slr033,50545slr037ltr.pdf 6/8/2003
AP08/20/2001SCP       
AP02/1/2002SLR       
AP02/26/2002SCS       
AP010/10/2002SCS       
AP012/2/2002SCS       
AP04/2/2004SLR8298050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50545slr050ltr.pdf 4/7/2004
AP07/27/2005SLR12393051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050545s051,052ltr.pdf 7/29/2005
AP07/27/2005SLR12394052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050545s051,052ltr.pdf 7/29/2005
AP04/17/2008SLR19691053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050545s053ltr.pdf 4/22/2008
AP04/17/2008SLR19942053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050545s053lbl.pdf 6/5/2008




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