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FDA Drug Application 020584 by WYETH PHARMS INC

Application Number020584
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
AP010/25/1996N       
AP02/3/1998SLR6639001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-584S001.pdf 9/11/2003
AP01/23/1998SCF       
AP05/27/1999SE23444003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-584S003_Lodine.cfm 7/18/2001
AP05/27/1999SE24793003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-584S003_Lodine_Approv.pdf 5/27/1999
AP05/27/1999SE24794003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-584S003_Lodine_prntlbl.pdf 5/27/1999
AP05/25/2005SLR11718004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020584s004,006,007ltr.pdf 5/26/2005
AP05/25/2005SLR11721004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf 5/26/2005
AP08/11/2000SE53443005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_LodineXL.cfm 11/9/2001
AP08/11/2000SE54791005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_Lodine_Approv.pdf 8/11/2000
AP08/11/2000SE54792005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_Lodine_prntlbl.pdf 8/11/2000
AP05/25/2005SLR11719006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020584s004,006,007ltr.pdf 5/26/2005
AP05/25/2005SLR11722006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf 5/26/2005
AP05/25/2005SLR11720007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020584s004,006,007ltr.pdf 5/26/2005
AP05/25/2005SLR11723007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf 5/26/2005
AP01/18/2006SLR13428009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018922s022,020584s009lbl.pdf 1/20/2006
AP01/18/2006SLR13468009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018922s022_020584s009ltr.pdf 1/20/2006




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