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FDA Drug Application 018922 by WYETH PHARMS INC

Application Number018922
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/31/1991N       
AP02/11/1992SCP       
AP010/28/1992SCF       
AP010/4/1991SLR       
AP011/25/1991SCS       
AP01/12/1993SCS       
AP01/12/1993SLR       
AP07/29/1993SCE       
AP07/29/1993SCF       
AP03/19/1993SCS       
AP012/8/1994SLR       
AP012/8/1994SLR       
AP06/28/1996SE1       
AP06/28/1996SCF       
AP06/28/1996SLR       
AP012/8/1997SCM       
AP05/24/2005SLR       
AP05/24/2005SLR       
AP05/24/2005SLR       
AP05/24/2005SLR       
AP05/24/2005SLR11728021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018922s021ltr.pdf 5/27/2005
AP05/24/2005SLR11742021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018922s021lbl.pdf 5/27/2005
AP01/18/2006SLR13429022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018922s022,020584s009lbl.pdf 1/20/2006
AP01/18/2006SLR13469022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018922s022_020584s009ltr.pdf 1/20/2006
AP010/11/2007SLR18236023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018922s023ltr.pdf 10/15/2007
AP010/11/2007SLR43497023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018922s023lbl.pdf 7/27/2015




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