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FDA Drug Application 013026 by WYETH PHARMS INC

Application Number013026
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
AP04/30/1965N       
AP06/20/1974S       
AP04/1/1981SCS       
AP010/26/1984SCF       
AP03/3/1987SCS       
AP06/4/1987SCP       
AP05/31/1988SCM       
AP06/21/1989SCS       
AP05/11/1990SCF       
AP04/26/1991SCS       
AP012/29/1992SCS       
AP03/18/1994SCS       
AP05/17/1994SCS       
AP04/23/1998SCM       
AP010/5/1998SCS       
AP011/12/1998SCF       
AP07/31/2001SCE       
AP010/3/2001SCS       
AP011/8/2004SCM10573022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13026s022,023ltr.pdf 11/15/2004
AP011/8/2004SCM10575022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf 11/15/2004
AP011/8/2004SCF10576023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf 11/15/2004
AP011/8/2004SCF10574023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13026s022,023ltr.pdf 11/15/2004
AP06/14/2006SLR14320024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013026s024lbl.pdf 6/20/2006
AP06/14/2006SLR14345024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/013026s024LTR.pdf 6/20/2006
AP04/29/2014SCM       
AP08/22/2016SLR46853029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/013026Orig1s029ltr.pdf 8/23/2016
AP08/22/2016SLR46862029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013026s029lbl.pdf 8/23/2016




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