Back to FDA Applications sponsored by MERCK

FDA Drug Application 021549 by MERCK

Application Number021549
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
AP03/27/2003N4662000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21549_Emend_lbl.pdf 3/28/2003
AP03/27/2003N4664000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21549ltr.pdf 3/28/2003
AP03/27/2003N6023000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-549_Emend.cfm 7/6/2003
AP01/15/2004SLR7593002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549slr002ltr.pdf 1/22/2004
AP01/15/2004SLR18500002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021549_S002_EMEND.pdf 11/19/2007
AP012/15/2004SLR10848004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549s004ltr.pdf 12/30/2004
AP012/15/2004SLR10886004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s004lbl.pdf 12/30/2004
AP012/22/2004SLR10825007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549s007ltr.pdf 12/29/2004
AP012/22/2004SLR10842007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s007lbl.pdf 12/29/2004
AP010/28/2005SE112991008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s008lbl.pdf 11/1/2005
AP010/28/2005SE113000008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021549s008ltr.pdf 11/1/2005
AP010/28/2005SE131992008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021549Orig1S008.pdf 3/2/2012
AP06/9/2005SLR11805009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021549s009ltr.pdf 6/14/2005
AP06/9/2005SLR11808009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s009lbl.pdf 6/14/2005
AP06/30/2006SE114396010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s010lbl.pdf 7/3/2006
AP06/30/2006SE114466010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021549s010LTR.pdf 7/13/2006
AP06/9/2006SLR14287011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021549s011rev1.pdf 6/12/2006
AP06/9/2006SLR14304011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s011lbl.pdf 6/14/2006
AP011/15/2007SLR18431012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021549s012lbl.pdf 11/19/2007
AP011/15/2007SLR18473012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021549s012ltr.pdf 11/19/2007
AP07/21/2009SLR23030014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021549s014ltr.pdf 7/23/2009
AP07/21/2009SLR23062014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s014lbl.pdf 7/23/2009
AP011/18/2008SLR21246015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021549s015lbl.pdf 11/19/2008
AP011/18/2008SLR21258015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021549s015ltr.pdf 11/21/2008
AP02/2/2009SLR21740016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021549s016ltr.pdf 2/4/2009
AP02/2/2009SLR21782016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s016lbl.pdf 2/4/2009
AP03/19/2010SE825099017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021549s017ltr.pdf 3/25/2010
AP03/19/2010SE825122017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021549s017lbl.pdf 3/26/2010
AP03/20/2013SLR35497019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s019ltr.pdf 3/22/2013
AP03/20/2013SLR35536019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s019lbl.pdf 3/26/2013
AP07/6/2012SLR33106021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021549s021lbl.pdf 7/10/2012
AP07/6/2012SLR33120021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021549Orig1s021ltr.pdf 7/11/2012
AP03/27/2013SLR35570023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s023,022023Orig1s010ltr.pdf 3/29/2013
AP03/27/2013SLR35605023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s023lbl.pdf 4/1/2013
AP08/12/2014SLR40221024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021549s024lbl.pdf 8/13/2014
AP08/12/2014SLR40230024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021549Orig1s024,022023Orig1s011ltr.pdf 8/14/2014
AP08/28/2015SE843770025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021549Orig1s025ltr.pdf 9/1/2015
AP08/28/2015SE843784025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021549s025lbl.pdf 9/3/2015
AP01/12/2015SCM       




Back to FDA Applications sponsored by MERCK