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FDA Drug Application 017473 by TEVA

Application Number017473
Application Type New Drug Application
Sponsor ApplicantTEVA
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
AP07/31/1984N       
AP011/14/1984SCM       
AP03/11/1985SLR       
AP03/21/1985SLR       
AP08/15/1985SCS       
AP04/20/1987SCE       
AP09/17/1986SLR       
AP010/7/1987SLR       
AP011/29/1988SCS       
AP010/27/1988SLR       
AP012/21/1990SLR       
AP012/16/1988SCS       
AP02/12/1990SCM       
AP07/27/1994SE5       
AP07/27/1994SLR       
AP012/21/1990SCM       
AP012/12/1994SCS       
AP05/10/1995SCM       
AP011/2/1994SCS       
AP010/20/1995SCS       
AP011/22/1995SCM       
AP011/22/1995SCM       
AP07/9/1996SCS       
AP01/7/1997SCS       
AP05/30/1997SCS       
AP08/27/1997SCM       
AP010/23/1997SCM       
AP03/23/1998SCS       
AP05/20/1998SLR       
AP011/9/1999SLR       
AP05/23/2000SCS       
AP011/12/1999SCM       
AP011/9/1999SLR       
AP011/14/2002SLR2683038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17473slr038ltr.pdf 11/14/2002
AP010/27/2003SLR6869039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17473slr039ltr.pdf 11/5/2003
AP04/28/2009SLR22432041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017473s041ltr.pdf 5/6/2009
AP04/28/2009SLR22493041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017473s041lbl.pdf 5/11/2009
AP07/19/2009SLR23008043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017473s043lbl.pdf 7/21/2009
AP07/19/2009SLR23027043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017473s043ltr.pdf 7/23/2009
AP012/1/2010SLR27182045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017473s045lbl.pdf 12/4/2010
AP012/1/2010SLR27198045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017473s045ltr.pdf 12/6/2010
AP09/27/2011SLR30166046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017473s046lbl.pdf 9/30/2011
AP09/27/2011SLR30183046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017473s046ltr.pdf 10/3/2011
AP09/27/2011SLR31534046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/017473Orig1s046.pdf 1/27/2012
AP08/1/2013SCM       
AP01/26/2015SCM       
AP05/11/2015SCM       




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