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FDA Drug Application 020637 by ARBOR PHARMS LLC

Application Number020637
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 Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/23/1996N35233000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020637Orig1s000.pdf 2/25/2013
AP010/8/1996SCM       
AP04/4/1997SCS       
AP09/15/1997SCS       
AP08/22/1997SCS       
AP01/22/1998SCS       
AP02/12/1998SCS       
AP010/16/1998SCS       
AP02/10/1999SCM       
AP03/25/1999SCS       
AP09/27/2000SCS       
AP07/16/1999SCS       
AP010/25/1999SCM       
AP08/8/2000SCS       
AP05/15/2001SCM       
AP02/25/2003SE14079016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020637s016lbl.pdf 3/5/2003
AP02/25/2003SE14269016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20637se1-016ltr.pdf 3/10/2003
AP02/25/2003SE16108016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-637s016_Gliadel.cfm 7/8/2003
AP011/7/2001SCM       
AP012/27/2006SLR15583022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020637s022ltr.pdf 1/8/2007
AP08/16/2013SLR36844026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020637Orig1s026ltr.pdf 8/20/2013
AP08/16/2013SLR36850026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020637s026lbl.pdf 8/21/2013
AP011/20/2014SLR41070027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020637Orig1s027ltr.pdf 11/24/2014
AP06/1/2015SCM       




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