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FDA Drug Application 020220 by BAYER HLTHCARE

Application Number020220
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
AP05/10/1995N       
AP05/30/1995SLR       
AP07/23/1997SE5       
AP06/5/1997SCS       
AP011/3/1998SCS       
AP011/25/1998SCS       
AP012/27/1999SCM       
AP04/25/2003SLR5731008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20220slr008ltr.pdf 5/29/2003
AP09/27/2000SCS       
AP010/24/2000SCM       
AP01/4/2001SCP       
AP011/5/2001SCM       
AP04/11/2002SCM       
AP010/30/2002SCM       
AP03/12/2004SCP7951018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20220scp018ltr.pdf 3/16/2004
AP03/12/2004SCP8264018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20220scp018_ultravist_lbl.pdf 4/5/2004
AP08/12/2005SLR12609022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020220s022ltr.pdf 8/15/2005
AP08/31/2007SLR17736027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020220s027lbl.pdf 9/4/2007
AP08/31/2007SLR17761027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020220s027ltr.pdf 9/6/2007
AP012/30/2009SE124418033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s033,021425s017ltr.pdf 1/5/2010
AP012/30/2009SE124486033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020220s033lbl.pdf 1/8/2010
AP011/13/2009SCM24553035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf 1/20/2010
AP05/2/2012SLR32620036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020220s036ltr.pdf 5/4/2012
AP05/2/2012SLR32641036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020220s036lbl.pdf 5/7/2012
AP07/29/2013SCM       
AP07/6/2015SLR43287041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf 7/9/2015
AP07/6/2015SLR43319041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020220Orig1s041,021425Orig1s024ltr.pdf 7/10/2015




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