Back to FDA Applications sponsored by SEBELA IRELAND LTD

FDA Drug Application 016324 by SEBELA IRELAND LTD

Application Number016324
Application Type New Drug Application
Sponsor ApplicantSEBELA IRELAND LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/20/1968N       
AP06/7/1978SCS       
AP03/21/1980SCS       
AP04/13/1981SES       
AP08/30/1994SLR       
AP02/26/1987SCS       
AP05/24/1988SCP       
AP010/17/1989SCP       
AP04/18/1988SCS       
AP07/9/1992SCM       
AP04/28/1992SCM       
AP010/26/1992SCS       
AP012/19/2002SLR9108026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16324slr026,17391slr011ltr.pdf 6/7/2004
AP07/26/2005SLR12353030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf 7/29/2005
AP07/26/2005SLR12354030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016324s030,017391s013ltr.pdf 7/29/2005
AP07/9/2008SLR20183031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf 7/10/2008
AP07/9/2008SLR20196031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016324s031, 017391s014LTR.pdf 7/14/2008
AP05/24/2011SLR28948034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf 5/25/2011
AP05/24/2011SLR28960034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf 5/26/2011
AP05/24/2011SLR28949035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf 5/25/2011
AP05/24/2011SLR28961035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf 5/26/2011
AP05/21/2014SCM       
AP02/6/2014SLR38475037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.pdf 2/7/2014
AP02/6/2014SLR38490037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016324Orig1s037,017391Orig1s016ltr.pdf 2/11/2014




Back to FDA Applications sponsored by SEBELA IRELAND LTD