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FDA Drug Application 020145 by MERCK SHARP DOHME

Application Number020145
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/4/1995SCF       
AP04/4/1995SCF       
AP04/14/1995SLR6427006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020145s006_nitro-dur_toc.cfm 8/7/2003
AP05/23/1995SLR6428007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020145s007_nitro-dur_toc.cfm 8/7/2003
AP011/8/1995SCM       
AP02/7/1996SLR       
AP06/4/1997SCS       
AP02/17/1999SLR       
AP08/23/2000SCM       
AP05/31/2001SCS       
AP03/7/2002SCS       
AP06/24/2004SLR9541015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20145slr015ltr.pdf 6/25/2004
AP010/18/2002SCS2968016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20145scs016ltr.pdf 10/18/2002
AP04/5/2005SLR11370021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20145s021ltr.pdf 4/12/2005
AP010/2/2014SLR40710027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020145Orig1s027ltr.pdf 10/3/2014
AP010/2/2014SLR40715027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020145s027lbl.pdf 10/3/2014
AP01/8/2016SCM       




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