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FDA Drug Application 017963 by US PHARMS HOLDINGS I

Application Number017963
Application Type New Drug Application
Sponsor ApplicantUS PHARMS HOLDINGS I
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
AP08/7/1978N       
AP011/5/1979SCP       
AP04/9/1979SCP       
AP04/9/1979SCM       
AP03/26/1979SCM       
AP08/7/1979SCP       
AP04/27/1979SCP       
AP010/24/1979SCP       
AP04/27/1979SCP       
AP010/10/1979SCM       
AP010/24/1979SCM       
AP01/17/1980SLR       
AP03/27/1981SCS       
AP05/12/1980SCS       
AP02/5/1980SCM       
AP01/17/1980SCP       
AP09/3/1980SCP       
AP01/30/1981SLR       
AP01/15/1981SCP       
AP04/20/1981SLR       
AP09/3/1981SCS       
AP03/26/1982SCE       
AP03/30/1984SES       
AP010/14/1982SCP       
AP05/17/1983SCP       
AP04/12/1983SES       
AP012/14/1984SCF       
AP02/28/1984SCS       
AP06/28/1984SCF       
AP06/27/1986SE1       
AP01/3/1985SCS       
AP07/30/1985SCS       
AP010/16/1985SCS       
AP011/20/1985SCF       
AP02/4/1988SCS       
AP05/31/1988SCP       
AP01/3/1989SCF       
AP010/26/1989SCF       
AP06/14/1990SLR       
AP01/30/1991SCM       
AP02/3/1995SCS       
AP011/2/1995SCM       
AP03/16/1999SLR       
AP02/18/1999SCM       
AP04/28/1999SCP       
AP05/10/2000SCM       
AP07/30/2001SCM       
AP04/29/2002SCM       
AP06/14/2002SCS       
AP09/12/2003SLR6669058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18704slr015,17963slr058ltr.pdf 9/25/2003
AP09/5/2006SLR14846059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018704s018, 017963s059_ltr.pdf 9/18/2006
AP01/8/2008SLR18797061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s061,018704s020ltr.pdf 1/9/2008
AP07/24/2008SLR20311062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf 7/29/2008
AP07/24/2008SLR20323062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s062,018704s021ltr.pdf 7/30/2008
AP011/20/2009SLR24098063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf 11/23/2009
AP011/20/2009SLR24453063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017963s063,018704s023ltr.pdf 1/6/2010
AP03/15/2011SLR28296064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017963s064lbl.pdf 3/21/2011
AP012/21/2012SLR34765067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017963Orig1s067ltr.pdf 12/26/2012
AP012/21/2012SLR34868067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017963s067lbl.pdf 1/11/2013
AP03/14/2013SLR35455068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017963Orig1s068ltr.pdf 3/15/2013
AP03/14/2013SLR35460068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017963s068lbl.pdf 3/15/2013
AP010/30/2014SCM       
AP010/30/2014SCM       
AP03/21/2016SCM       




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