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FDA Drug Application 021425 by BAYER HLTHCARE

Application Number021425
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
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
AP09/20/2002N1873000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21425ltr.pdf 9/20/2002
AP09/20/2002N1874000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21425lbl.pdf 9/20/2002
AP09/20/2002N6015000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021425_ultravist.cfm 6/26/2003
AP01/23/2003SLR9605001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21425slr001ltr.pdf 6/29/2004
AP03/12/2004SCP7950006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21425scp006ltr.pdf 3/16/2004
AP03/12/2004SCP8225006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21425scp006_ultravist_lbl.pdf 4/5/2004
AP08/31/2007SLR17735012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021425s012lbl.pdf 9/4/2007
AP08/31/2007SLR17760012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021425s012ltr.pdf 9/6/2007
AP06/23/2010SE125832017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021425s017ltr.pdf 6/29/2010
AP06/23/2010SE125884017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021425s017lbl.pdf 7/1/2010
AP011/13/2009SCM24554019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf 1/20/2010
AP05/2/2012SLR32642020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021425s020lbl.pdf 5/7/2012
AP07/6/2015SLR43286024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf 7/9/2015
AP07/6/2015SLR43320024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020220Orig1s041,021425Orig1s024ltr.pdf 7/10/2015




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