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FDA Drug Application 013400 by MERCK

Application Number013400
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
AP012/20/1962N       
AP06/6/1975SCS       
AP01/6/1976SLR       
AP012/12/1975SCS       
AP07/22/1976SLR       
AP011/9/1976SCS       
AP08/31/1976SLR       
AP011/9/1976SCS       
AP02/7/1977SLR       
AP05/2/1977SCP       
AP02/15/1978SCP       
AP05/6/1977SLR       
AP05/6/1977SCP       
AP08/24/1978SCS       
AP06/8/1978SLR       
AP07/25/1979SLR       
AP010/21/1977SCM       
AP08/29/1978SCS       
AP010/30/1978SCS       
AP011/7/1978SCS       
AP03/9/1979SCS       
AP07/25/1979SLR       
AP010/10/1979SCS       
AP04/7/1982SCF       
AP011/14/1980SCP       
AP01/23/1981SCS       
AP04/9/1981SCS       
AP08/28/1981SCS       
AP011/17/1981SLR       
AP06/17/1981SCP       
AP08/28/1981SCF       
AP010/14/1981SLR       
AP05/11/1987SPD       
AP04/7/1982SCF       
AP09/8/1982SLR       
AP04/19/1982SCM       
AP03/1/1983SCP       
AP012/23/1983SCF       
AP03/1/1984SLR       
AP04/10/1984SCP       
AP07/13/1984SLR       
AP01/17/1985SCS       
AP02/22/1985SLR       
AP010/22/1985SLR       
AP05/11/1987SLR       
AP04/26/1988SCM       
AP011/22/1988SLR       
AP09/13/1990SLR       
AP09/3/1992SLR       
AP012/16/1994SLR       
AP09/26/1994SCM       
AP011/30/1995SCM       
AP08/5/1997SLR       
AP07/7/1997SCS       
AP07/7/1997SCS       
AP08/5/1997SLR       
AP011/10/1998SLR       
AP09/17/2004SLR10234086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13400s086lbl.pdf 9/21/2004
AP09/17/2004SLR10235086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13400s086ltr.pdf 9/21/2004




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