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FDA Drug Application 021693 by SHIONOGI INC

Application Number021693
Application Type New Drug Application
Sponsor ApplicantSHIONOGI INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/5/2005N11627000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021693ltr.pdf 5/17/2005
AP05/5/2005N11654000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021693lbl.pdf 5/17/2005
AP05/5/2005N17689000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021693s000TOC.cfm 8/22/2007
AP07/12/2006SCP14511001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021693s001ltr.pdf 7/21/2006
AP08/13/2010SLR26302002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s002lbl.pdf 8/28/2010
AP08/13/2010SLR26365002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021693s002ltr.pdf 9/7/2010
AP06/25/2010SLR25836004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021693s004ltr.pdf 6/29/2010
AP06/25/2010SLR25891004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s004lbl.pdf 7/1/2010




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