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FDA Drug Application 022044 by MERCK SHARP DOHME

Application Number022044
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/30/2007N16160000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022044lbl.pdf 4/6/2007
AP03/30/2007N16174000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022044s000ltr.pdf 4/9/2007
AP03/30/2007N20165000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022044TOC.cfm 7/8/2008
AP03/30/2007N25033000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM204268.pdf 3/16/2010
AP03/30/2007N35856000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183768.htm 4/29/2013
AP01/2/2008SLR18730002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf 1/8/2008
AP01/2/2008SLR18794002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s002, s005, s006ltr.pdf 1/9/2008
AP02/26/2008SE819317003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s003s004lbl.pdf 2/28/2008
AP02/26/2008SE819336003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s003, s004ltr.pdf 2/29/2008
AP02/26/2008SE819318004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s003s004lbl.pdf 2/28/2008
AP02/26/2008SE819337004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s003, 004ltr.pdf 2/29/2008
AP01/2/2008SLR18731005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf 1/8/2008
AP01/2/2008SLR18795005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s002, s005, s006ltr.pdf 1/9/2008
AP01/2/2008SLR18732006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022044s002s005s006lbl.pdf 1/8/2008
AP01/2/2008SLR18796006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s002, s005, s006ltr.pdf 1/9/2008
AP05/1/2008SCM19779007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s007ltr.pdf 5/7/2008
AP010/20/2008SCA21065009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022044s009ltr.pdf 10/23/2008
AP02/26/2010SE824893010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf 3/2/2010
AP02/26/2010SE824896010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013MedGuide.pdf 3/2/2010
AP02/26/2010SE824958010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s010s012s013ltr.pdf 3/4/2010
AP012/28/2009SLR24388011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022044s011lbl.pdf 12/31/2009
AP012/28/2009SLR24509011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022044s011ltr.pdf 1/14/2010
AP02/26/2010SE824894012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf 3/2/2010
AP02/26/2010SE824897012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013MedGuide.pdf 3/2/2010
AP02/26/2010SE824959012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s010s012s013ltr.pdf 3/4/2010
AP02/26/2010SLR24895013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s010s012s013lbl.pdf 3/2/2010
AP02/26/2010SLR24960013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s010s012s013ltr.pdf 3/4/2010
AP09/24/2010SE826560014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s014,s018ltr.pdf 9/29/2010
AP09/24/2010SE826565014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s014s018lbl.pdf 9/29/2010
AP06/10/2011SLR29215015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP04/14/2011SLR28561016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf 4/18/2011
AP04/14/2011SLR28575016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022044s016ltr.pdf 4/19/2011
AP04/14/2011SLR28816016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022044s016(1)ltr.pdf 5/16/2011
AP04/14/2011SLR28839016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf 5/16/2011
AP15/13/2011SLR28561016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf 4/18/2011
AP15/13/2011SLR28575016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022044s016ltr.pdf 4/19/2011
AP15/13/2011SLR28816016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022044s016(1)ltr.pdf 5/16/2011
AP15/13/2011SLR28839016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022044s016lbl.pdf 5/16/2011
AP09/24/2010SLR26561018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022044s014,s018ltr.pdf 9/29/2010
AP09/24/2010SLR26566018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022044s014s018lbl.pdf 9/29/2010
AP03/24/2012SLR32201022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022044s022ltr.pdf 3/27/2012
AP03/24/2012SLR32214022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s022lbl.pdf 3/27/2012
AP03/24/2012SLR32215022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s022mg.pdf 3/27/2012
AP010/18/2012SLR34135026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022044Orig1s026ltr.pdf 10/22/2012
AP010/18/2012SLR34153026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s026lbl.pdf 10/22/2012
AP010/18/2012SLR34154026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022044s026mg.pdf 10/22/2012
AP02/7/2013SLR35109027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022044s027lbl.pdf 2/8/2013
AP02/7/2013SLR35117027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022044Orig1s027ltr.pdf 2/8/2013
AP06/28/2013SCM       
AP09/11/2013SLR37121029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022044s029lbl.pdf 9/17/2013
AP09/11/2013SLR37205029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022044Origs029ltr.pdf 9/24/2013
AP03/18/2014SCM       
AP01/5/2015SCM       
AP06/12/2015SCM       
AP04/27/2015SLR42693034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf 4/29/2015
AP04/27/2015SLR42729034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022044s034lbl.pdf 5/4/2015
AP08/28/2015SLR43768035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf 9/1/2015
AP08/28/2015SLR43804035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022044s035lbl.pdf 9/4/2015




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