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FDA Drug Application 021043 by BAYER HEALTHCARE LLC

Application Number021043
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE LLC
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
AP03/7/2000N1024000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21043ltr.pdf 3/7/2000
AP03/7/2000N1025000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21043lbl.pdf 3/7/2000
AP03/7/2000N9388000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-043_RID.cfm 6/16/2004
AP09/22/2000SCS       
AP03/27/2001SCM       
AP010/25/2002SCS       
AP012/20/2004SLR10852005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21043s005ltr.pdf 12/30/2004
AP05/26/2006SLR14190006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021043s006LTR.pdf 5/30/2006




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