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FDA Drug Application 022023 by MERCK AND CO INC

Application Number022023
Application Type New Drug Application
Sponsor ApplicantMERCK AND CO INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/25/2008N18961000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022023s000ltr.pdf 1/29/2008
AP01/25/2008N18972000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022023lbl.pdf 1/30/2008
AP01/25/2008N22306000   http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/022023s000TOC.cfm 4/22/2009
AP03/23/2010SLR25103002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf 3/25/2010
AP03/23/2010SLR25115002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf 3/26/2010
AP03/23/2010SLR25116003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf 3/26/2010
AP03/23/2010SLR25104003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf 3/25/2010
AP011/12/2010SE226963004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s004lbl.pdf 11/17/2010
AP011/12/2010SE226978004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s004ltr.pdf 11/18/2010
AP011/12/2010SE238305004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022023Orig1s004.pdf 1/17/2014
AP03/23/2010SLR25117005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022023s002s003s005lbl.pdf 3/26/2010
AP03/23/2010SLR25105005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022023s002s003s005ltr.pdf 3/25/2010
AP02/1/2016SE845083006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022023s006lbl.pdf 2/2/2016
AP02/1/2016SE845092006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022023Orig1s006ltr.pdf 2/3/2016
AP03/20/2013SLR35487007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022023Orig1s007ltr.pdf 3/22/2013
AP03/20/2013SLR35537007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s007lbl.pdf 3/26/2013
AP07/6/2012SLR33107009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022023s009lbl.pdf 7/10/2012
AP07/6/2012SLR33119009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022023Orig1s009ltr.pdf 7/11/2012
AP03/27/2013SLR35571010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s023,022023Orig1s010ltr.pdf 3/29/2013
AP03/27/2013SLR35604010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022023s010lbl.pdf 4/1/2013
AP08/12/2014SLR40220011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022023s011lbl.pdf 8/13/2014
AP08/12/2014SLR40231011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021549Orig1s024,022023Orig1s011ltr.pdf 8/14/2014
AP01/12/2015SCM       




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