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FDA Drug Application 019625 by MERCK SHARP DOHME

Application Number019625
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
AP05/6/1987N       
AP010/29/1987SCM       
AP010/3/1995SE5       
AP09/25/1991SCS       
AP04/16/1996SCS       
AP03/7/1997SCP       
AP05/21/1998SCS       
AP06/5/1998SCM       
AP012/28/1998SCM       
AP011/10/1998SCP       
AP04/13/2000SCS       
AP07/17/2002SLR1758012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19625slr012,se5-013ltr.pdf 7/17/2002
AP07/17/2002SLR1759012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf 7/17/2002
AP07/17/2002SE51760013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19625slr012,se5-013ltr.pdf 7/17/2002
AP07/17/2002SE51761013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf 7/17/2002
AP04/19/2013S35813024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019625s024lbl.pdf 4/23/2013
AP04/19/2013S35832024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019625Orig1s024ltr.pdf 4/24/2013




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