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FDA Drug Application 021762 by MERCK

Application Number021762
Application Type New Drug Application
Sponsor ApplicantMERCK
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
AP04/7/2005N11373000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021762ltr.pdf 4/12/2005
AP04/7/2005N11381000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021762lbl.pdf 4/12/2005
AP04/7/2005N14260000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021762s000_FosamaxTOC.cfm 6/8/2006
AP04/7/2005N18697000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 1/7/2008
AP04/7/2005N36007000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241521.pdf 5/9/2013
AP011/2/2005SLR13032001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021762s001lbl.pdf 11/8/2005
AP011/2/2005SLR13039001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021762s001ltr.pdf 11/8/2005
AP012/28/2006SLR15597002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf 1/8/2007
AP012/28/2006SLR15625002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf 1/8/2007
AP012/28/2006SLR15598003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf 1/8/2007
AP012/28/2006SLR15626003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf 1/8/2007
AP04/26/2007SE216343004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021762s004lbl.pdf 5/1/2007
AP04/26/2007SE216371004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021762s004ltr.pdf 5/1/2007
AP03/1/2010SLR24890005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf 3/2/2010
AP03/1/2010SLR24943005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021762s005s009sS010ltr.pdf 3/3/2010
AP010/8/2008SCA20981006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020560s052, 021575s013, 021762s006ltr.pdf 10/9/2008
AP010/8/2008SCA21160006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf 11/7/2008
AP03/1/2010SLR24891009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf 3/2/2010
AP03/1/2010SLR24944009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021762s005s009sS010ltr.pdf 3/3/2010
AP03/1/2010SLR24892010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf 3/2/2010
AP03/1/2010SLR24945010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021762s005s009sS010ltr.pdf 3/3/2010
AP01/25/2011SLR27605013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021762s013MedG.pdf 1/26/2011
AP01/25/2011SLR27606013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021762s013lbl.pdf 1/26/2011
AP01/25/2011SLR27618013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021762s013ltr.pdf 1/27/2011
AP07/1/2011SLR29418015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021762s015ltr.pdf 7/6/2011
AP04/19/2013SLR35775017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021762Orig1s017ltr.pdf 4/23/2013
AP04/19/2013SLR35805017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021762s017lbl.pdf 4/23/2013
AP011/7/2013SLR37754018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021762Orig1s018ltr.pdf 11/8/2013
AP011/7/2013SLR37761018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021762s018lbl.pdf 11/8/2013
AP07/10/2015SCM       
AP04/8/2015SLR42487020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021762s020lbl.pdf 4/10/2015
AP04/8/2015SLR42505020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021762Orig1s020ltr.pdf 4/13/2015
AP011/30/2015SLR44631021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021762Orig1s021ltr.pdf 12/1/2015
AP011/30/2015SLR44650021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021762s021lbl.pdf 12/2/2015




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