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FDA Drug Application 050297 by ARBOR PHARMS INC

Application Number050297
Application Type New Drug Application
Sponsor ApplicantARBOR PHARMS INC
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
AP08/6/1970N       
AP04/14/1997SLR       
AP02/4/2000SLR10240018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-207s054s55_50-297s018_50-611s018_Erthromycin.cfm 9/21/2004
AP04/25/2002SLR1796019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50207s057.pdf 4/25/2002
AP08/10/2006SLR14666021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050207s058,050297s021lbl.pdf 8/11/2006
AP08/10/2006SLR14697021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050207s058, 050297s021LTR.pdf 8/14/2006
AP03/12/2004SLR7953024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50611slr024,50297slr024,50207slr061ltr.pdf 3/16/2004
AP01/5/2008SLR18736027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s027lbl.pdf 1/8/2008
AP01/5/2008SLR18807027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050297s027ltr.pdf 1/9/2008
AP05/22/2008SLR19888028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050297s028ltr.pdf 5/28/2008
AP011/4/2010SLR26904029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050207s067,050297s029ltr.pdf 11/8/2010
AP012/10/2008SLR21364030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050207s068, 050297s030ltr.pdf 12/19/2008
AP012/10/2008SLR21490030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s030,050207s068lbl.pdf 1/2/2009
AP08/15/2012SLR33491031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050297s031lbl.pdf 8/16/2012
AP08/15/2012SLR33495031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050297Orig1s031ltr.pdf 8/17/2012




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