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FDA Drug Application 050596 by US PHARM HOLDINGS

Application Number050596
Application Type New Drug Application
Sponsor ApplicantUS PHARM HOLDINGS
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
AP05/20/1985N       
AP06/13/1985SLR       
AP09/23/1985SLR       
AP07/23/1985SLR       
AP03/5/1992SCF       
AP08/7/1989SCS       
AP08/10/1992SCS       
AP09/24/1996SLR       
AP05/19/1994SCM       
AP011/22/1994SLR       
AP06/16/1994SCM       
AP09/14/1994SLR       
AP09/2/1994SLR       
AP04/30/1996SLR       
AP012/23/1996SLR       
AP04/24/1997SLR       
AP01/18/2002SLR2468023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf 1/18/2002
AP02/18/2000SCM       
AP04/10/2001SCS       
AP04/12/2001SCM       
AP07/27/2001SCM       
AP09/6/2001SCS       
AP06/23/2004SLR9525030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr030ltr.pdf 6/24/2004
AP09/2/2004SLR       
AP02/21/2008SLR19283035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf 2/25/2008
AP02/21/2008SLR19289035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050596s035ltr.pdf 2/25/2008
AP05/27/2009SLR22670036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050547s067,050596s036ltr.pdf 6/2/2009
AP09/9/2011SLR29986037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037ltr.pdf 9/13/2011
AP09/9/2011SLR30024037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf 9/16/2011
AP05/3/2013SCM       
AP02/21/2014SLR38571040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050547Orig1s070,050596Orig1s040ltr.pdf 2/25/2014
AP02/21/2014SLR38582040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf 2/25/2014
AP04/21/2014SCM       
AP03/23/2015SLR42246042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050547Orig1s071,050596Orig1s042ltr.pdf 3/24/2015
AP03/23/2015SLR42527042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf 4/14/2015




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