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FDA Drug Application 020171 by FRESENIUS MEDCL

Application Number020171
Application Type New Drug Application
Sponsor ApplicantFRESENIUS MEDCL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/19/1992N       
AP03/10/1994SCS       
AP03/8/1996SCS       
AP01/19/1996SCS       
AP02/22/1996SCS       
AP06/14/1996SCS       
AP02/24/1997SCS       
AP05/18/1999SCP       
AP09/26/2001SCP       
AP011/26/2003SCS7022010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18883scs028,20171scs010ltr.pdf 12/2/2003
AP09/14/2009SLR23861015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018883s033,020171s015ltr.pdf 11/13/2009
AP01/30/2013SLR35041026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s044,020171s026lbl.pdf 2/1/2013
AP01/30/2013SLR35051026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018883Orig1s044,020171Orig1s026ltr.pdf 2/4/2013
AP02/22/2013SCM       
AP04/18/2013SCM35754030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s048,020171s030lbl.pdf 4/19/2013
AP04/24/2014SLR39146033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018883Orig1s051,20171Orig1s033ltr.pdf 4/25/2014
AP04/24/2014SLR39155033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018883s051,020171s033lbl.pdf 4/28/2014
AP01/13/2014SCM       
AP01/24/2014SCM       
AP04/23/2014SCM       
AP01/8/2015SLR41569039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018883Orig1s057,020171Orig1s039ltr.pdf 1/9/2015
AP01/8/2015SLR41613039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018883Orig1s057,020171Orig1s039lbl.pdf 1/12/2015
AP03/24/2016SCM       




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