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FDA Drug Application 012892 by SHIRE

Application Number012892
Application Type New Drug Application
Sponsor ApplicantSHIRE
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
AP09/13/1962N       
AP012/6/1979SLR       
AP05/13/1980SLR       
AP05/6/1999SLR33964015   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/012892Orig1s015s016lbl.pdf 10/4/2012
AP05/6/1999SLR33966015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/012892Orig1s015,s016ltr.pdf 10/4/2012
AP05/6/1999SLR33967016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/012892Orig1s015,s016ltr.pdf 10/4/2012
AP05/6/1999SLR33965016   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/012892Orig1s015s016lbl.pdf 10/4/2012




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