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FDA Drug Application 020304 by BAYER HLTHCARE

Application Number020304
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
AP012/29/1993N13663000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142720.htm 2/27/2006
AP02/7/1994SCE       
AP010/12/1994SE2       
AP01/19/1995SLR       
AP08/28/1998SE1258004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020304s004.cfm 7/2/1999
AP08/28/1998SE1259004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20304s04.pdf 8/28/1998
AP08/28/1998SE1260004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20304s04.pdf 8/28/1998
AP08/8/1997SLR       
AP09/30/1997SLR       
AP03/5/1999SLR       
AP09/21/1999SLR       
AP07/24/2000SLR13585009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s009lbl.pdf 2/7/2006
AP04/11/2001SCS       
AP09/18/2001SCP       
AP012/15/2006SLR15477022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s022lbl.pdf 12/15/2006
AP012/15/2006SLR15546022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020304s022ltr.pdf 12/28/2006




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