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FDA Drug Application 018631 by US PHARM HOLDINGS

Application Number018631
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
AP08/30/1984N       
AP05/13/1985SLR       
AP010/4/1985SCF       
AP04/24/1986SLR       
AP05/27/1986SCS       
AP09/3/1987SCS       
AP01/27/1988SLR       
AP07/28/1989SCE       
AP02/23/1990SCF       
AP011/7/1991SLR       
AP010/30/1990SCS       
AP011/7/1991SLR       
AP03/27/1991SCS       
AP04/30/1991SCM       
AP012/16/1991SCP       
AP02/11/1993SCM       
AP011/24/1993SCS       
AP011/4/1994SCS       
AP07/25/1994SLR       
AP07/28/1995SLR       
AP04/4/1995SCP       
AP04/10/1995SCS       
AP01/2/1996SCF       
AP02/9/1996SCS       
AP06/18/1996SCS       
AP04/29/1997SLR4344030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018631_s030ap.pdf 4/29/1997
AP011/3/1997SCM       
AP09/30/2003SLR6741033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18631slr033ltr.pdf 10/9/2003
AP04/7/2005SLR11377034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018631s034ltr.pdf 4/12/2005
AP04/7/2005SLR11385034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018631s034lbl.pdf 4/12/2005
AP04/17/2014SLR39095036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018631Orig1s036ltr.pdf 4/18/2014
AP07/3/2012SLR33091039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018631s039ltr.pdf 7/9/2012
AP07/3/2012SLR33114039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018631s039lbl.pdf 7/10/2012
AP02/13/2015SLR41855040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018631Orig1s040ltr.pdf 2/17/2015
AP02/13/2015SLR42314040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018631s040lbl.pdf 3/27/2015
AP01/15/2016SLR44980041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018631Orig1s041ltr.pdf 1/20/2016
AP01/15/2016SLR45178041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018631s041lbl.pdf 2/17/2016




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