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FDA Drug Application 020070 by SHIONOGI INC

Application Number020070
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/9/1993N       
AP06/15/1995SLR       
AP06/15/1995SLR       
AP010/10/1997SLR3671004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020070ap.pdf 10/10/1997
AP02/21/1996SCS       
AP010/10/1997SE23672006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020070ap.pdf 10/10/1997
AP07/15/1997SCM       
AP07/2/1998SLR       
AP010/15/1998SCS       
AP06/19/2003SCM5955012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20070scm012,slr013ltr.pdf 6/22/2003
AP06/19/2003SLR5956013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20070scm012,slr013ltr.pdf 6/22/2003




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