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FDA Drug Application 018445 by MERCK

Application Number018445
Application Type New Drug Application
Sponsor ApplicantMERCK
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
AP04/19/1982N       
AP02/3/1986SCS       
AP010/27/1983SLR       
AP010/27/1983SLR       
AP01/9/1985SLR       
AP06/25/1984SCM       
AP05/3/1984SCM       
AP012/11/1984SCS       
AP010/3/1984SCM       
AP011/20/1984SCM       
AP02/21/1985SCM       
AP02/21/1985SCM       
AP09/30/1985SCM       
AP02/3/1986SCS       
AP04/21/1989SCM       
AP02/2/1988SLR       
AP08/15/1986SLR       
AP08/15/1986SLR       
AP02/2/1988SLR       
AP03/28/1994SCS       
AP02/2/1988SLR       
AP02/2/1988SLR       
AP02/2/1988SLR       
AP02/2/1988SLR       
AP02/2/1988SLR       
AP05/3/1988SCM       
AP01/9/1989SLR       
AP04/21/1989SCM       
AP01/9/1989SCP       
AP01/9/1989SLR       
AP011/19/1991SCS       
AP012/6/1991SCS       
AP012/6/1991SLR       
AP08/22/1994SLR       
AP08/22/1994SLR       
AP08/22/1994SLR       
AP08/18/1994SCS       
AP04/17/1997SLR       
AP03/1/1996SCM       
AP05/15/1998SLR       
AP05/15/1998SLR       
AP012/1/1997SCS       
AP01/24/2006SLR13481057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018445s057lbl.pdf 1/25/2006
AP01/24/2006SLR13529057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018445s057ltr.pdf 1/30/2006
AP03/16/2007SLR16072058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018445s058ltr.pdf 3/23/2007
AP03/16/2007SLR16094058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018445s058lbl.pdf 3/23/2007




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