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FDA Drug Application 021995 by MERCK SHARP DOHME

Application Number021995
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/16/2006N15127000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf 10/18/2006
AP010/16/2006N15182000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021995s000ltr.pdf 10/23/2006
AP010/16/2006N15454000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021995s000TOC.cfm 12/13/2006
AP010/16/2006N25032000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM204269.pdf 3/16/2010
AP010/16/2006N35857000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183768.htm 4/29/2013
AP07/22/2008S       
AP010/12/2007SE818285002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf 10/22/2007
AP010/12/2007SE818286003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf 10/22/2007
AP010/12/2007SLR18287004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf 10/22/2007
AP010/12/2007SLR18288006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf 10/22/2007
AP07/22/2008SLR20278007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021995s007ltr.pdf 7/23/2008
AP07/22/2008SLR20283007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021995s007lbl.pdf 7/23/2008
AP010/20/2008SLR21064009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021995s009ltr.pdf 10/23/2008
AP02/26/2010SE824899010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf 3/2/2010
AP02/26/2010SE824980010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf 3/5/2010
AP02/26/2010SE824903010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014MedGuide.pdf 3/2/2010
AP02/26/2010SE824904011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014MedGuide.pdf 3/2/2010
AP02/26/2010SE824982011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf 3/5/2010
AP02/26/2010SE824900011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf 3/2/2010
AP02/26/2010SE824901012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf 3/2/2010
AP02/26/2010SE824983012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf 3/5/2010
AP02/26/2010SE824905012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014MedGuide.pdf 3/2/2010
AP012/28/2009SLR24490013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021995s013lbl.pdf 1/12/2010
AP012/28/2009SLR24508013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021995s013ltr.pdf 1/14/2010
AP012/28/2009SLR42091013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021995Orig1s013.pdf 3/11/2015
AP02/26/2010SLR42092014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021995Orig1s014.pdf 3/11/2015
AP02/26/2010SLR24985014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf 3/5/2010
AP02/26/2010SLR24902014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf 3/2/2010
AP09/24/2010SE826558015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s015,s018ltr.pdf 9/29/2010
AP09/24/2010SE826567015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf 9/29/2010
AP06/10/2011SLR29216016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP04/14/2011SLR28562017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf 4/18/2011
AP04/14/2011SLR28576017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021995s017ltr.pdf 4/19/2011
AP09/24/2010SLR26568018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf 9/29/2010
AP09/24/2010SLR26559018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s015,s018ltr.pdf 9/29/2010
AP02/27/2012SCM31926019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s019lbl.pdf 2/27/2012
AP03/23/2012SLR32200023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021995s023ltr.pdf 3/27/2012
AP03/23/2012SLR32216023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s023lbl.pdf 3/27/2012
AP03/23/2012SLR32217023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s023mg.pdf 3/27/2012
AP010/18/2012SLR34134025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021995Orig1s025ltr.pdf 10/22/2012
AP010/18/2012SLR34151025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s025lbl.pdf 10/22/2012
AP010/18/2012SLR34152025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s025mg.pdf 10/22/2012
AP012/7/2012SCM       
AP02/7/2013SLR35110027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf 2/8/2013
AP02/7/2013SLR35118027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021995Orig1s027ltr_replacement.pdf 2/8/2013
AP010/17/2013SCM37505028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s028lbl.pdf 10/22/2013
AP08/19/2013SLR36864029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s029lbl.pdf 8/21/2013
AP08/19/2013SLR36869029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021995Orig1s029ltr.pdf 8/22/2013
AP03/10/2015SCM42106032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s032ltr.pdf 3/12/2015
AP03/10/2015SCM42127032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s032lbl.pdf 3/12/2015
AP04/27/2015SLR42691033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf 4/29/2015
AP04/27/2015SLR42728033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s033lbl.pdf 5/4/2015
AP08/28/2015SLR43767034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf 9/1/2015
AP08/28/2015SLR43805034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf 9/4/2015
AP01/11/2016SCM       




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