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FDA Drug Application 018063 by US WORLDMEDS LLC

Application Number018063
Application Type New Drug Application
Sponsor ApplicantUS WORLDMEDS LLC
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
AP012/10/1979N       
AP02/11/1980SLR       
AP02/11/1980SLR       
AP08/14/1980SCM       
AP01/27/1981SCF       
AP010/22/1980SCS       
AP012/30/1980SLR       
AP03/17/1981SCS       
AP01/27/1981SCP       
AP08/28/1981SCP       
AP04/2/1981SCS       
AP07/9/1981SCF       
AP07/24/1981SCF       
AP08/28/1981SCS       
AP010/15/1981SCE       
AP03/2/1982SCS       
AP04/1/1982SCS       
AP06/2/1982SCS       
AP010/1/1982SCS       
AP09/22/1982SCM       
AP011/18/1982SCP       
AP03/29/1983SCM       
AP03/29/1983SCS       
AP07/21/1983SCS       
AP010/14/1983SCS       
AP011/1/1983SCE       
AP011/16/1984SES       
AP01/17/1984SCS       
AP02/8/1984SCP       
AP03/6/1984SCP       
AP05/16/1984SCE       
AP010/28/1986SE2       
AP05/15/1984SCS       
AP05/16/1984SCS       
AP08/6/1984SCS       
AP010/24/1984SCP       
AP05/15/1985SLR       
AP010/7/1986SCS       
AP08/19/1986SCS       
AP03/11/1987SCE       
AP01/6/1987SCP       
AP08/21/1990SCS       
AP09/3/1987SCP       
AP011/7/1990SLR       
AP03/29/1991SCM       
AP05/3/1991SCS       
AP011/8/1991SCM       
AP05/20/1992SCM       
AP05/1/1992SCF       
AP04/5/1994SCS       
AP08/16/1995SCM       
AP03/18/1996SCS       
AP09/19/2001SCM       
AP02/4/2008SLR19071060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018063s060ltr.pdf 2/7/2008
AP02/4/2008SLR19131060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018063s060lbl.pdf 2/14/2008
AP06/6/2011SLR29053062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018063s062ltr.pdf 6/7/2011
AP06/6/2011SLR29281062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018063s062lbl.pdf 6/27/2011
AP07/15/2013SLR36562063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018063s063lbl.pdf 7/15/2013
AP07/15/2013SLR36563063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018063Orig1s063ltr.pdf 7/16/2013




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