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FDA Drug Application 103132 by SCHERING

Application Number103132
Application Type Biologic License Application
Sponsor ApplicantSCHERING
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/4/1986N158400000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111337.pdf 2/20/2007
AP03/26/1997S       
AP011/6/1997S79731116   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ifnasch110697L.htm 3/17/2004
AP011/6/1997S79741116   http://www.accessdata.fda.gov/drugsatfda_docs/bla/1997/ifnasch110697r.pdf 3/17/2004
AP011/6/1997S79751116   http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/ifnasch110697-lab.pdf 3/17/2004
AP04/29/1997S       
AP08/18/1998S       
AP05/22/2007S165965059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5095ltr.pdf 5/29/2007
AP010/27/2004S110145064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103132_5064ltr.pdf 1/26/2005
AP010/27/2004S110495064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103132_5064lbl.pdf 1/26/2005
AP07/28/2006S150885086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103132s5086ltr.pdf 10/13/2006
AP07/28/2006S151335086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103132s5086lbl.pdf 10/18/2006
AP05/22/2007S166415095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5095ltr.pdf 5/29/2007
AP05/22/2007S166425095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5095lbl.pdf 5/29/2007
AP07/13/2007S173445096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5096ltr.pdf 7/24/2007
AP07/13/2007S173595096   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5096lbl.pdf 7/24/2007
AP05/2/2008S199095108   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103132s5108ltr.pdf 5/30/2008
AP02/1/2011S278545143   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103132s5143ltr.pdf 2/15/2011
AP012/20/2011S312325161   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103132s5161lbl.pdf 12/23/2011
AP012/20/2011S312775161   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103132s5161ltr.pdf 12/28/2011
AP06/4/2012SLR328465163   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103132s5163ltr.pdf 6/7/2012
AP011/15/2013SLR378425178   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103132Orig1s5178ltr.pdf 11/18/2013
AP011/15/2013SLR378975178   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103132s5178lbl.pdf 11/22/2013
AP04/2/2014SLR389675183   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5183lbl.pdf 4/3/2014
AP08/11/2014SLR402045190   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103132Origs5190ltr.pdf 8/12/2014
AP08/11/2014SLR402115190   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5190lbl.pdf 8/12/2014
AP05/21/2015SLR428925191   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103132Orig1s5191ltr.pdf 5/26/2015
AP05/21/2015SLR429135191   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103132s5191lbl.pdf 5/27/2015




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