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FDA Drug Application 010402 by WYETH PHARMS INC

Application Number010402
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
AP012/18/1956N22676000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm 6/2/2009
AP04/29/1985SLR       
AP09/11/1989SLR       
AP01/7/1986SCF       
AP01/28/1988SCF       
AP03/2/1989SCS       
AP09/26/1989SCS       
AP011/27/1989SCP       
AP07/12/1993SCS       
AP02/24/1993SLR       
AP02/6/1995SCM       
AP012/14/1995SCS       
AP05/29/1998SLR       
AP010/17/2002SCS       
AP010/9/2002SCM       
AP04/20/2004SLR8399046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010402S046lbl.pdf 4/23/2004
AP04/20/2004SLR8427046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10402slr046ltr.pdf 4/29/2004
AP01/14/2005SLR11008047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/10402s047,20216s053ltr.pdf 1/21/2005
AP01/14/2005SLR11009047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/10402s047lbl.pdf 1/21/2005
AP08/30/2005SLR12717048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.pdf 9/7/2005
AP08/30/2005SLR12718048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010402s048,020216s054ltr.pdf 9/7/2005
AP07/26/2006SLR14542050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010402s050,020216s055lbl.pdf 7/27/2006
AP07/26/2006SLR14621050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s050, 020216s055LTR.pdf 8/4/2006
AP06/1/2006SCS14245051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010402s051LTR.pdf 6/6/2006
AP02/29/2008SLR19355055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/010402s055ltr.pdf 3/4/2008
AP02/29/2008SLR19367055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/010402s055lbl.pdf 3/5/2008
AP04/11/2012SLR32432063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/010402Orig1s063ltr.pdf 4/13/2012
AP04/11/2012SLR32439063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010402s063lbl.pdf 4/17/2012
AP09/15/2016SCM       




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