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FDA Drug Application 017962 by US PHARMS HOLDINGS I

Application Number017962
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
AP06/28/1978N       
AP02/7/1980SCM       
AP02/16/1979SCS       
AP02/27/1979SCM       
AP05/17/1979SCP       
AP09/23/1981SOA       
AP07/29/1982SCS       
AP02/4/1981SCP       
AP02/6/1981SCP       
AP012/14/1984SLR       
AP03/1/1982SCS       
AP06/11/1981SCM       
AP02/16/1984SCS       
AP08/26/1982SCS       
AP07/29/1982SCS       
AP07/29/1982SCS       
AP011/30/1983SCS       
AP06/28/1985SES       
AP012/14/1984SLR       
AP09/17/1985SCS       
AP01/21/1987SCS       
AP01/28/1987SLR       
AP07/1/1987SLR       
AP012/31/1991SLR       
AP06/4/1990SCP       
AP012/19/1989SCP       
AP03/2/1989SCS       
AP010/22/1990SCS       
AP010/22/1990SCS       
AP010/22/1990SCS       
AP06/9/1992SCS       
AP05/29/1992SLR       
AP012/11/1991SLR       
AP05/29/1992SLR       
AP04/1/1993SCP       
AP04/1/1993SCM       
AP05/25/1994SLR       
AP03/13/1995SCS       
AP07/29/1994SCP       
AP06/9/1995SCS       
AP02/8/1995SLR       
AP03/24/1995SLR       
AP010/10/1995SCS       
AP011/28/1995SCM       
AP07/3/1996SLR       
AP04/2/1998SLR       
AP011/9/1999SLR       
AP08/13/1998SCM       
AP09/3/1998SCM       
AP04/22/1999SCP       
AP09/10/1999SCM       
AP010/1/1999SCM       
AP05/1/2000SCM       
AP05/22/2001SCS       
AP011/20/2001SCM       
AP02/21/2002SCM       
AP011/9/2005SLR13054063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf 11/17/2005
AP011/9/2005SLR13074063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017962s063,064ltr.pdf 11/17/2005
AP011/9/2005SLR14071063   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/017962_s063_s064_ParlodelTOC.cfm 5/8/2006
AP011/9/2005SLR13055064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf 11/17/2005
AP011/9/2005SLR13075064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017962s063,064ltr.pdf 11/17/2005
AP011/9/2005SLR14072064   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/017962_s063_s064_ParlodelTOC.cfm 5/8/2006
AP01/5/2012SLR31355065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017962s065,s068ltr.pdf 1/6/2012
AP01/5/2012SLR31367065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf 1/6/2012
AP01/5/2012SLR31354068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017962s065,s068ltr.pdf 1/6/2012
AP01/5/2012SLR31368068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf 1/6/2012
AP07/31/2013SCM       
AP02/27/2014SCM       
AP06/13/2016SCM       
AP011/26/2014SCM       
AP09/27/2016SCM       




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