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FDA Drug Application 020482 by BAYER HLTHCARE

Application Number020482
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/6/1995N       
AP01/16/1996SLR       
AP012/13/1996SLR       
AP05/29/1997SCF       
AP010/10/1997SCM       
AP011/20/1997SCM       
AP09/29/1998SE1592007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20482s7-8ltr.pdf 9/29/1998
AP09/29/1998SE1593007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020482a_s007_s008.pdf 9/29/1998
AP09/29/1998SE1677008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20482s7-8ltr.pdf 9/29/1998
AP09/29/1998SE1678008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020482a_s007_s008.pdf 9/29/1998
AP02/4/1998SLR       
AP08/16/1999SE81008010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020482S010_Precose.cfm 8/16/1999
AP08/16/1999SE84991010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020482S010_Precose_appltr.pdf 8/16/1999
AP010/29/2002SLR3680011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20482slr011ltr.pdf 10/29/2002
AP06/27/2000SCM       
AP07/29/2005SLR12498015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020482s015ltr.pdf 8/3/2005
AP07/29/2005SLR12509015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020482s015lbl.pdf 8/3/2005
AP08/23/2008SLR20662023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020482s023ltr.pdf 8/25/2008
AP08/23/2008SLR20669023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020482s023lbl.pdf 8/26/2008
AP03/24/2011SLR28347024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020482s024ltr.pdf 3/25/2011
AP03/24/2011SLR28387024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020482s024lbl.pdf 3/28/2011
AP02/29/2012SLR31980025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020482s025lbl.pdf 3/1/2012
AP02/29/2012SLR31984025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020482s025ltr.pdf 3/2/2012
AP011/11/2014SCM       
AP03/9/2015SLR42089027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020482Orig1s027ltr.pdf 3/11/2015
AP03/9/2015SLR42303027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020482s027lbl.pdf 3/27/2015




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