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FDA Drug Application 019856 by MERCK SHARP DOHME

Application Number019856
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/30/1991N       
AP05/10/1999SLR       
AP012/24/1992SCF       
AP010/7/1993SCS       
AP05/16/1996SCP       
AP05/7/1996SCM       
AP05/10/1999SLR       
AP05/10/1999SLR       
AP05/10/1999SLR       
AP06/10/1998SCM       
AP08/4/1999SCS       
AP05/10/1999SLR       
AP06/6/2000SCM       
AP05/2/2000SLR       
AP07/17/2014SLR39918016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf 7/22/2014
AP07/17/2014SLR39928016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf 7/23/2014
AP03/16/2001SCM       
AP03/16/2001SCS       
AP010/11/2001SCM       
AP09/5/2002SCM       
AP07/17/2014SLR39929024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf 7/23/2014
AP07/17/2014SLR39919024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf 7/22/2014
AP012/31/2008SLR21512025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019856s025ltr.pdf 1/6/2009
AP012/31/2008SLR21536025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019856s025lbl.pdf 1/6/2009
AP02/1/2011SCM27718027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019856s027lbl.pdf 2/4/2011
AP02/1/2011SCM27751027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017555s070,019856s027ltr.pdf 2/7/2011
AP07/17/2014SLR39920028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf 7/22/2014
AP07/17/2014SLR39930028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf 7/23/2014




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