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FDA Drug Application 050742 by MERCK SHARP DOHME

Application Number050742
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/22/1996N3748000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050742ap.pdf 11/26/1997
AP010/8/1998SCF11218001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50-742s001_Stromectol.cfm 3/8/2005
AP01/4/2001SLR       
AP08/4/1999SCS       
AP011/10/1999SCS       
AP01/4/2001SLR       
AP07/17/2001SCS       
AP05/28/2002SCS       
AP012/12/2002SCM       
AP01/15/2003SLR4186011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50742slr011ltr.pdf 1/15/2003
AP01/15/2003SLR4187011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50742slr011_stromectol_lbl.pdf 1/15/2003
AP02/12/2004S7728012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50742slr012,013ltr.pdf 2/27/2004
AP02/12/2004S7810012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742slr012,013_stomectol_lbl.pdf 3/3/2004
AP02/12/2004SLR7811013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742slr012,013_stomectol_lbl.pdf 3/3/2004
AP02/12/2004SLR7729013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50742slr012,013ltr.pdf 2/27/2004
AP011/18/2004SLR10656015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742s015lbl.pdf 12/2/2004
AP01/20/2006SLR13515017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050742s017,s018lbl.pdf 1/27/2006
AP01/20/2006SLR13561017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050742s017ltr.pdf 1/30/2006
AP01/20/2006SLR13562018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050742s017ltr.pdf 1/30/2006
AP01/20/2006SLR13516018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050742s017,s018lbl.pdf 1/27/2006
AP09/26/2007SLR18040019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050742s019s021lbl.pdf 9/26/2007
AP09/26/2007SLR18148019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050742s019, 050742s021ltr.pdf 10/4/2007
AP02/26/2008SCM19311020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050742s020ltr.pdf 2/27/2008
AP09/26/2007SLR18041021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050742s019s021lbl.pdf 9/26/2007
AP09/26/2007SLR18147021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050742s019, 050742s021ltr.pdf 10/4/2007
AP09/12/2008SLR20781022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050742s022ltr.pdf 9/16/2008
AP09/12/2008SLR20786022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050742s022lbl.pdf 9/16/2008
AP05/1/2009SLR22484023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s023lbl.pdf 5/11/2009
AP06/11/2009SLR22762024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s024,s025ltr.pdf 6/17/2009
AP06/11/2009SLR22782024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s024s025lbl.pdf 6/22/2009
AP06/11/2009SLR22783025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s024s025lbl.pdf 6/22/2009
AP06/11/2009SLR22763025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s024,s025ltr.pdf 6/17/2009
AP012/15/2009SLR24297026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s026lbl.pdf 12/16/2009
AP012/15/2009SLR24344026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s026ltr.pdf 12/24/2009
AP04/7/2015SCM       
AP05/11/2015SCM       




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