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FDA Drug Application 020408 by MERCK

Application Number020408
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/9/1994N       
AP04/25/1995SCP       
AP03/23/1995SCF       
AP010/31/1995SCS       
AP010/31/1995SCM       
AP07/22/1996SCS       
AP08/3/1998SLR       
AP08/3/1998SLR       
AP02/20/1997SCS       
AP06/13/1997SCS       
AP08/3/1998SLR       
AP08/3/1998SLR       
AP012/12/1997SCS       
AP08/3/1998SLR       
AP010/19/1998SCS       
AP012/1/1998SLR       
AP06/6/1999SLR       
AP09/27/1999SLR       
AP02/15/2000SLR       
AP01/18/2001SCM       
AP09/18/2000SLR       
AP012/4/2001SCM       
AP05/15/2002SLR4115023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20408s23ltr.pdf 4/12/2002
AP05/15/2002SLR4116023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20408s23lbl.pdf 4/12/2002
AP04/15/2002SCM       
AP05/15/2002SLR4113025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20408s25ltr.pdf 4/9/2002
AP05/15/2002SLR4114025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20408S25lbl.pdf 4/9/2002
AP04/19/2002SCM       
AP012/6/2002SCP       
AP04/15/2004SE58368033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20408se5-033ltr.pdf 4/20/2004
AP04/15/2004SE58470033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20408se5-033_trusopt_lbl.pdf 5/3/2004
AP04/15/2004SE520378033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020408_S033_TRUSOPT.pdf 7/31/2008
AP012/16/2005SLR13335039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020408s039lbl.pdf 1/5/2006
AP012/16/2005SLR13410039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020408s039ltr.pdf 1/19/2006
AP010/22/2008SLR21077045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020408s045ltr.pdf 10/24/2008
AP010/22/2008SLR21158045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020408s045lbl.pdf 11/7/2008
AP06/18/2010SLR25762047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020408s047ltr.pdf 6/22/2010
AP06/18/2010SLR25788047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020408s047lbl.pdf 6/24/2010
AP02/3/2014SLR38463050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020408s050lbl.pdf 2/6/2014
AP02/3/2014SLR38483050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020408Orig1s050ltr.pdf 2/10/2014




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