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FDA Drug Application 018303 by US PHARMS HOLDINGS I

Application Number018303
Application Type New Drug Application
Sponsor ApplicantUS PHARMS HOLDINGS I
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/1984N       
AP03/26/1985SCP       
AP02/22/1985SLR       
AP010/23/1985SCP       
AP05/31/1988SCP       
AP09/23/1988SLR       
AP012/9/1988SCF       
AP06/14/1990SLR       
AP09/18/1991SLR       
AP011/8/1991SCF       
AP02/2/1995SLR       
AP07/31/1995SCS       
AP03/4/1996SCM       
AP06/7/1996SCS       
AP01/8/1997SCS       
AP011/7/1997SLR       
AP02/18/1999SCM       
AP04/28/1999SCP       
AP05/12/2000SCS       
AP05/10/2000SCM       
AP07/30/2001SCM       
AP02/8/2002SCP       
AP04/29/2002SCM       
AP06/14/2002SCS       
AP010/31/2003SLR6930025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18303slr025ltr.pdf 11/25/2003
AP09/7/2006SLR14848029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018303s029_ltr.pdf 9/18/2006
AP01/8/2008SLR18741032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s032lbl.pdf 1/8/2008
AP01/8/2008SLR18799032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018303s032ltr.pdf 1/9/2008
AP07/24/2008SLR20308033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s033lbl.pdf 7/29/2008
AP07/24/2008SLR20597033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018303s033ltr.pdf 8/13/2008
AP08/7/2009SLR23372034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018303s034lbl.pdf 9/17/2009
AP08/7/2009SLR24457034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018303s034ltr.pdf 1/6/2010
AP03/15/2011SLR28294035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf 3/21/2011
AP03/15/2011SLR28295036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf 3/21/2011




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