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FDA Drug Application 018654 by HLR

Application Number018654
Application Type New Drug Application
Sponsor ApplicantHLR
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
AP012/20/1985N       
AP05/28/1986SCM       
AP05/28/1986SCS       
AP010/17/1988SLR       
AP02/25/1987SLR       
AP05/26/1987SLR       
AP05/26/1987SCS       
AP08/20/1987SCS       
AP02/25/1988SLR       
AP09/29/1989SCS       
AP09/19/1991SLR       
AP010/4/1990SCM       
AP010/4/1990SCM       
AP012/31/1996SLR3773018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018654ap.pdf 11/20/1997
AP09/19/1991SLR       
AP03/12/1993SCM       
AP02/26/1993SCS       
AP02/26/1993SCS       
AP02/19/1999SLR       
AP07/22/1993SCS       
AP07/6/1995SCM       
AP04/26/1994SE1       
AP02/19/1999SLR       
AP012/31/1996SE23774029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018654ap.pdf 11/20/1997
AP03/18/1997SE23776030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018654ap.pdf 11/20/1997
AP05/11/1998SCM       
AP010/23/1998SCS       
AP012/17/1998SCS       
AP08/25/1998SLR       
AP012/20/1999SCS       
AP09/4/2001SLR       




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