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FDA Drug Application 017391 by SEBELA IRELAND LTD

Application Number017391
Application Type New Drug Application
Sponsor ApplicantSEBELA IRELAND LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/19/1974N       
AP09/20/1978SCM       
AP04/23/1982SLR       
AP08/30/1994SPD       
AP03/23/1992SCS       
AP09/2/1993SCM       
AP011/9/1994SCM       
AP012/19/2002SLR6142011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16324slr026,17391slr011ltr.pdf 7/24/2003
AP09/26/1997SCM       
AP07/26/2005SLR12352013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf 7/29/2005
AP07/26/2005SLR12355013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016324s030,017391s013ltr.pdf 7/29/2005
AP07/9/2008SLR20182014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf 7/10/2008
AP07/9/2008SLR20197014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016324s031, 017391s014LTR.pdf 7/14/2008
AP05/24/2011SLR28950015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017391s015lbl.pdf 5/25/2011
AP05/24/2011SLR28962015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf 5/26/2011
AP02/6/2014SLR38474016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.pdf 2/7/2014
AP02/6/2014SLR38491016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016324Orig1s037,017391Orig1s016ltr.pdf 2/11/2014




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