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FDA Drug Application 022411 by ANGELINI PHARMA

Application Number022411
Application Type New Drug Application
Sponsor ApplicantANGELINI PHARMA
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
AP02/2/2010N24700000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM202202.pdf 2/4/2010
AP02/2/2010N24701000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022411lbl.pdf 2/4/2010
AP02/2/2010N24731000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022411s000ltr.pdf 2/5/2010
AP02/2/2010N26020000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022411_oleptro_toc.cfm 7/27/2010
AP02/2/2010N26021000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022411s000SumR.pdf 7/27/2010
AP05/5/2011SLR28742004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022411s004lbl.pdf 5/6/2011
AP05/5/2011SLR28743004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022411s004MedG.pdf 5/6/2011
AP05/5/2011SLR28751004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022411s004ltr.pdf 5/10/2011
AP05/11/2011S       
AP05/11/2011S       
AP011/13/2012SLR34378007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022411Orig1s007ltr.pdf 11/14/2012
AP011/13/2012SLR34398007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022411s007lbl.pdf 11/15/2012
AP07/17/2014SLR39897008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022411Orig1s008ltr.pdf 7/21/2014
AP07/17/2014SLR39910008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022411s008lbl.pdf 7/22/2014




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