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FDA Drug Application 019716 by MERCK SHARP DOHME

Application Number019716
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
AP08/1/1988N       
AP04/6/1989SCP       
AP05/24/1989SLR       
AP08/1/1990SCS       
AP07/1/1992SCP       
AP010/7/2005SLR12878006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019716s006ltr.pdf 10/14/2005
AP010/7/2005SLR12887006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019716s006lbl.pdf 10/14/2005
AP01/25/1996SCM       
AP06/15/1998SCS       
AP07/31/1998SCS       
AP05/14/1999SCS       
AP09/7/2000SCP       
AP05/11/2001SCS       
AP04/24/2006SLR13991021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s021LTR.pdf 4/25/2006
AP08/28/2006SE514772022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019716s022lbl.pdf 8/28/2006
AP08/28/2006SE514873022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s022ltr.pdf 9/18/2006
AP08/13/2014SLR40239030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf 8/14/2014
AP08/13/2014SLR40255030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019716s030lbl.pdf 8/15/2014




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