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FDA Drug Application 019816 by WYETH PHARMS INC

Application Number019816
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
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
AP09/24/1993N       
AP02/8/1995SCF       
AP02/8/1995SLR       
AP02/10/1995SCM       
AP03/21/1996SCM       
AP03/21/1996SCM       
AP03/21/1996SCS       
AP08/5/1997SLR6633007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-754S025.pdf 9/11/2003
AP01/18/2006SLR13426010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018754s027,019816s010lbl.pdf 1/20/2006
AP01/18/2006SLR13465010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018754s027_019816s010ltr.pdf 1/20/2006
AP07/31/2007SLR17457011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019816s011lbl.pdf 8/2/2007
AP07/31/2007SLR17473011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019816s011ltr.pdf 8/2/2007




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