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FDA Drug Application 016792 by ODYSSEY PHARMS

Application Number016792
Application Type New Drug Application
Sponsor ApplicantODYSSEY PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/12/1979N16538000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP06/12/1979N34542000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM330750.pdf 12/4/2012
AP07/8/1980SLR       
AP03/26/1981SCP       
AP09/15/1982SCF       
AP08/24/1981SCS       
AP010/5/1982SCP       
AP011/12/1982SCP       
AP02/2/1987SCP       
AP07/24/1987SCM       
AP06/17/1988SCP       
AP04/20/1988SCM       
AP012/16/1991SCS       
AP04/27/2000SLR3330015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf 5/2/2002
AP04/3/1992SCM       
AP04/3/1992SCS       
AP04/27/2000SLR3331018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf 5/2/2002
AP04/27/2000SLR3332019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf 5/2/2002
AP05/1/2000SLR3333020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S020.pdf 5/2/2002
AP01/12/2005SLR10979024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16792s024ltr.pdf 1/13/2005
AP01/12/2005SLR10999024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16792s024lbl.pdf 1/13/2005
AP08/1/2007SLR17444025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016792s025lbl.pdf 8/2/2007
AP08/1/2007SLR17581025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016792s025ltr.pdf 8/7/2007
AP012/3/2012SLR34535034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016792s034lbl.pdf 12/3/2012
AP012/3/2012SLR34556034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016792Orig1s034ltr.pdf 12/5/2012
AP012/23/2013SCM       
AP09/30/2014SCM       
AP07/17/2014SLR39896037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016792Orig1s037ltr.pdf 7/21/2014
AP07/17/2014SLR40055037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf 7/29/2014




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