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FDA Drug Application 074755 by MYLAN SPECLT

Application Number074755
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN SPECLT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/10/1997N       
AP010/14/1997SL       
AP05/24/2000SCR       
AP05/24/2000SCP       
AP01/31/2001SS       
AP012/18/2001SCS       
AP012/20/2002SCB       
AP012/20/2002SS       
AP02/20/2007SCP       
AP012/7/2012SLR41260025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/074755Orig1s025ltr.pdf 12/16/2014
AP012/7/2012SLR41316025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074755Orig1s025lbl.pdf 12/19/2014




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