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FDA Drug Application 018883 by FRESENIUS MEDCL

Application Number018883
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
AP011/30/1984N       
AP09/5/1985SCE       
AP06/16/1986SCM       
AP06/16/1986SLR       
AP010/27/1987SCS       
AP010/27/1987SLR       
AP07/21/1987SCS       
AP01/14/1987SLR       
AP04/8/1987SCS       
AP01/24/1990SCS       
AP01/24/1990SLR       
AP01/24/1990SCS       
AP01/24/1990SLR       
AP02/5/1988SCS       
AP01/10/1989SCS       
AP07/11/1990SCS       
AP07/7/1993SCM       
AP07/7/1993SLR       
AP07/7/1993SCM       
AP01/19/1996SCS       
AP02/22/1996SCS       
AP06/14/1996SCS       
AP02/24/1997SCS       
AP05/18/1999SCP       
AP09/26/2001SCP       
AP011/26/2003SCS7021028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18883scs028,20171scs010ltr.pdf 12/2/2003
AP09/14/2009SLR23862033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018883s033,020171s015ltr.pdf 11/13/2009
AP01/30/2013SLR35042044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s044,020171s026lbl.pdf 2/1/2013
AP01/30/2013SLR35050044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018883Orig1s044,020171Orig1s026ltr.pdf 2/4/2013
AP02/22/2013SCM       
AP04/18/2013SCM35755048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s048,020171s030lbl.pdf 4/19/2013
AP08/15/2013SCM       
AP07/26/2013SCM       
AP04/24/2014SLR39145051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018883Orig1s051,20171Orig1s033ltr.pdf 4/25/2014
AP04/24/2014SLR39154051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018883s051,020171s033lbl.pdf 4/28/2014
AP01/13/2014SCM       
AP01/24/2014SCM       
AP04/23/2014SCM       
AP08/7/2014SCM       
AP012/8/2014SCM       
AP01/8/2015SLR41568057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018883Orig1s057,020171Orig1s039ltr.pdf 1/9/2015
AP01/8/2015SLR41612057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018883Orig1s057,020171Orig1s039lbl.pdf 1/12/2015
AP012/28/2015SCM       
AP010/17/2016SCM       
AP07/18/2016SCM       




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