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FDA Drug Application 020807 by BAYER HLTHCARE

Application Number020807
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
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
AP03/6/1998N3143000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20807_Refludan_Approv.pdf 3/6/1998
AP03/6/1998N4860000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20807_Refludan.cfm 4/4/2003
AP03/6/1998N5030000Approvable Letter  http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20807_Refludan_Approvableltr.pdf 9/8/1997
AP011/17/1998SCS       
AP03/4/1999SLR       
AP04/1/1999SCM       
AP04/2/2003SLR5382005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20807slr005ltr.pdf 4/18/2003
AP011/7/2006SLR15329011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020807s011lbl.pdf 11/9/2006
AP011/7/2006SLR15342011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020807s011ltr.pdf 11/13/2006
AP03/9/2007SLR16023015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020807s015ltr.pdf 3/15/2007




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