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FDA Drug Application 015034 by SHIONOGI INC

Application Number015034
Application Type New Drug Application
Sponsor ApplicantSHIONOGI INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/28/1967N24054000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088692.pdf 11/20/2009
AP04/28/1975SFP       
AP04/27/1977SCP       
AP010/18/1977SCS       
AP02/17/1981SCS       
AP02/17/1981SLR       
AP01/29/1981SCF       
AP05/14/1981SCM       
AP03/2/1981SCM       
AP02/5/1981SCM       
AP01/26/1982SCS       
AP03/31/1983SLR       
AP04/19/1983SCM       
AP08/13/1984SCS       
AP01/31/1986SCS       
AP05/29/1984SCM       
AP06/14/1989SCF       
AP06/14/1989SLR       
AP010/4/1993SCS       
AP04/5/1996SCM       
AP04/23/1998SLR20555032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/015034_S032_PONSTEL.pdf 8/11/2008
AP09/1/1998SCM       
AP010/4/2001SLR20472034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/015034_S034_PONSTEL.pdf 8/4/2008
AP07/31/2001SCM       
AP01/18/2006SLR13424039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/015034s039lbl.pdf 1/20/2006
AP01/18/2006SLR13463039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/015034s039ltr.pdf 1/20/2006
AP03/6/2008SLR19398040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015034s040lbl.pdf 3/7/2008
AP03/6/2008SLR19479040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015034s040ltr.pdf 3/17/2008
AP01/5/2015SCM       
AP05/9/2016SLR45929044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015034Orig1s044ltr.pdf 5/11/2016
AP05/9/2016SLR45981044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf 5/11/2016




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