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FDA Drug Application 050611 by ARBOR PHARMS LLC

Application Number050611
Application Type New Drug Application
Sponsor ApplicantARBOR PHARMS LLC
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
AP09/9/1986N       
AP09/25/1989SB       
AP09/25/1989SB       
AP02/4/1987SCM       
AP05/15/1987SCS       
AP010/8/1987SCS       
AP07/13/1987SLR       
AP09/25/1989SB       
AP08/22/1990SCG       
AP05/18/1993SLR       
AP05/20/1987SCS       
AP01/5/1988SLR       
AP04/14/1997SLR       
AP05/14/1998SCP       
AP02/4/2000SLR10239018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-207s054s55_50-297s018_50-611s018_Erthromycin.cfm 9/21/2004
AP04/25/2002SLR1797019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50207s057.pdf 4/25/2002
AP08/9/2006SLR14668022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050611s022lbl.pdf 8/11/2006
AP08/9/2006SLR14696022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050611s022LTR.pdf 8/14/2006
AP03/12/2004SLR7952024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50611slr024,50297slr024,50207slr061ltr.pdf 3/16/2004
AP01/27/2011SLR27644027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050611s027lbl.pdf 1/31/2011
AP01/27/2011SLR27749027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050611s027ltr.pdf 2/7/2011
AP01/5/2008SLR18734029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s029lbl.pdf 1/8/2008
AP01/5/2008SLR18808029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s029ltr.pdf 1/9/2008
AP05/22/2008SLR19889030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s030ltr.pdf 5/28/2008
AP011/4/2010SLR26905031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050611s031ltr.pdf 11/8/2010
AP012/10/2008SLR21374032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050611s032ltr.pdf 12/19/2008
AP012/10/2008SLR21489032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050611s032lbl.pdf 1/2/2009
AP02/2/2012SLR31658035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050207s071,050611s035ltr.pdf 2/6/2012
AP02/2/2012SLR31679035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050611s035lbl.pdf 2/6/2012




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