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FDA Drug Application 050547 by US PHARM HOLDINGS

Application Number050547
Application Type New Drug Application
Sponsor ApplicantUS PHARM HOLDINGS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/11/1981N       
AP01/14/1983SCM       
AP012/29/1983SCP       
AP08/23/1983SCM       
AP02/29/1984SLR       
AP012/14/1984SCE       
AP09/16/1985SCM       
AP06/24/1985SCM       
AP010/25/1985SCS       
AP07/14/1987SLR       
AP08/13/1981SCM       
AP06/20/1988SCF       
AP08/7/1989SLR       
AP09/24/1996SLR       
AP05/19/1994SCM       
AP06/30/1992SCP       
AP08/17/1995SCM       
AP011/22/1994SLR       
AP01/19/1993SCS       
AP011/12/1993SCM       
AP09/14/1994SLR       
AP09/2/1994SLR       
AP010/20/1993SCS       
AP07/22/1981SCM       
AP010/5/1981SLR       
AP010/19/1981SLR       
AP02/5/1982SCP       
AP02/23/1982SLR       
AP07/26/1982SLR       
AP06/29/1982SLR       
AP04/30/1996SLR       
AP08/25/1995SCS       
AP09/27/1996SE2       
AP012/23/1996SLR       
AP04/24/1997SLR       
AP01/18/2002SLR2467047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf 1/18/2002
AP03/16/1998SCS       
AP010/28/1997SCS       
AP06/26/1998SCM       
AP06/16/1998SCS       
AP02/18/2000SCM       
AP04/10/2001SCS       
AP04/12/2001SCM       
AP07/27/2001SCM       
AP09/6/2001SCS       
AP02/22/2002SCM       
AP06/23/2004N9524060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr030ltr.pdf 6/24/2004
AP09/2/2004SLR10120061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547s061ltr.pdf 9/3/2004
AP02/21/2008SLR19281066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf 2/25/2008
AP02/21/2008SLR19288066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050547s066ltr.pdf 2/25/2008
AP05/27/2009SLR22669067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050547s067,050596s036ltr.pdf 6/2/2009
AP09/9/2011SLR29985068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037ltr.pdf 9/13/2011
AP09/9/2011SLR30025068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf 9/16/2011
AP02/21/2014SLR38570070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050547Orig1s070,050596Orig1s040ltr.pdf 2/25/2014
AP02/21/2014SLR38583070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf 2/25/2014
AP03/23/2015SLR42245071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050547Orig1s071,050596Orig1s042ltr.pdf 3/24/2015
AP03/23/2015SLR42528071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf 4/14/2015




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