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FDA Drug Application 014602 by MERCK SHARP DOHME

Application Number014602
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP03/3/1965N       
AP08/8/1979SLR       
AP011/4/1982SCM       
AP06/30/1982SCM       
AP06/10/1986SCM       
AP05/1/1990SCM       
AP07/1/1987SCS       
AP02/6/1992SCM       
AP012/17/1992SLR       
AP09/7/1993SLR       
AP03/14/1994SCP       
AP04/13/1994SLR       
AP05/3/1995SCS       
AP07/12/2006SLR14515019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014602s019ltr.pdf 7/21/2006
AP011/13/1996SCM       
AP07/21/1997SCS       
AP07/15/1999SCS       
AP010/8/1999SCS       
AP04/10/2000SCS       
AP07/24/2001SCS       
AP06/24/2008SLR20077047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/014602s047lbl.pdf 6/26/2008
AP06/24/2008SLR20095047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/014602s047ltr.pdf 6/30/2008
AP01/9/2013SCM       
AP03/13/2013SCM36206056   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/014602Orig1s056.pdf 6/4/2013
AP05/21/2014SCM       
AP07/3/2014SLR39782058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014602Orig1s058ltr.pdf 7/8/2014
AP07/3/2014SLR39808058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014602s058lbl.pdf 7/8/2014
AP02/4/2015SLR41787059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/014602s059lbl.pdf 2/5/2015
AP02/4/2015SLR41803059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/014602Orig1s059ltr.pdf 2/6/2015




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