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FDA Drug Application 103694 by WYETH PHARMS INC

Application Number103694
Application Type Biologic License Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/25/1997N80430000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/opregen112597L.htm 3/25/2004
AP011/25/1997N80440000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080674.htm 3/25/2004
AP02/13/2009SLR219391008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103694s1008ltr.pdf 3/3/2009
AP02/13/2009SLR220591008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103694s1008lbl.pdf 3/19/2009
AP09/18/2002S80461009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/opregen091802L.pdf 3/25/2004
AP09/18/2002S80471009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/opregen091802LB.pdf 3/25/2004
AP09/18/2002S80485004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/opregen0918022L.pdf 3/25/2004
AP09/18/2002S80495004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/opregen091802LB.pdf 3/25/2004
AP05/25/2004S91915024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103694-5024ltr.pdf 5/25/2004
AP09/13/2006S149075065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103694_5065ltr.pdf 9/20/2006
AP09/13/2006S149215065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103694_5065lbl.pdf 9/20/2006
AP08/10/2006S147225066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103694s5066LTR.pdf 8/18/2006
AP08/10/2006S147425066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103694s5066LBL.pdf 8/21/2006




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