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FDA Drug Application 021174 by WYETH PHARMS INC

Application Number021174
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/17/2000N1386000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21174ltr.pdf 5/17/2000
AP05/17/2000N1387000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21174lbl.pdf 5/17/2000
AP05/17/2000N3658000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21174_Mylotorg.cfm 6/4/2001
AP010/27/2000SLR       
AP02/23/2001SLR5442002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21174s2lbl.pdf 4/23/2003
AP05/25/2001SLR       
AP012/19/2001SCS       
AP04/19/2002SCS       
AP04/19/2002SCS       
AP08/23/2002SCS       
AP04/16/2004SE88360012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21174se8-012ltr.pdf 4/20/2004
AP06/23/2004SLR9529014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21174slr014ltr.pdf 6/24/2004
AP07/23/2004SCP9851015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21174s015ltr.pdf 7/28/2004
AP01/23/2006SE813495020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021174s020lbl.pdf 1/25/2006
AP01/23/2006SE813546020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021174s020ltr.pdf 1/30/2006
AP06/14/2005SLR11816021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021174s021ltr.pdf 6/15/2005
AP010/4/2005SLR12910024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021174s024ltr.pdf 10/20/2005




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