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FDA Drug Application 021575 by MERCK

Application Number021575
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/17/2003N6672000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21575ltr.pdf 9/25/2003
AP09/17/2003N6695000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21575_fosomax_lbl.pdf 9/25/2003
AP09/17/2003N11358000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-575_Fosamax.cfm 4/8/2005
AP09/17/2003N18696000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 1/7/2008
AP09/17/2003N33057000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf 6/29/2012
AP04/27/2004SLR8448002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr030,21575slr002ltr.pdf 4/29/2004
AP02/20/2004SLR7798003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr042,21517slr003ltr.pdf 3/3/2004
AP02/20/2004SLR8198003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fosamax_lbl.pdf 4/5/2004
AP02/20/2004SLR17005003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020560_S042 & 021575_S003_FOSAMAX_TABS_ORAL_SOLUTION_AP.pdf 7/6/2007
AP04/16/2004SLR8367004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560se8-041,21575slr004ltr.pdf 4/20/2004
AP04/16/2004SLR8469004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560se8-041,21575slr004_fosamax_lbl.pdf 5/3/2004
AP04/16/2004SLR20355004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021575_s004_FOSAMAX TABS.pdf 7/31/2008
AP012/1/2004SLR10766005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf 12/8/2004
AP012/1/2004SLR10768005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf 12/8/2004
AP012/1/2004SLR10769006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf 12/8/2004
AP012/1/2004SLR10767006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf 12/8/2004
AP012/21/2005SLR13337007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020560s038_021575s007lbl.pdf 1/5/2006
AP012/21/2005SLR13367007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s038,021575s007.pdf 1/6/2006
AP011/2/2005SLR13020009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021575s009,020560s046lbl.pdf 11/3/2005
AP011/2/2005SLR13038009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s046,021575s009ltr.pdf 11/8/2005
AP012/28/2006SLR15599010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf 1/8/2007
AP012/28/2006SLR15623010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf 1/8/2007
AP012/28/2006SLR15624011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf 1/8/2007
AP012/28/2006SLR15600011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf 1/8/2007
AP03/1/2010SLR24884012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf 3/2/2010
AP03/1/2010SLR24973012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf 3/5/2010
AP010/8/2008SCA20980013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020560s052, 021575s013, 021762s006ltr.pdf 10/9/2008
AP010/8/2008SCA21161013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf 11/7/2008
AP03/1/2010SLR24885016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf 3/2/2010
AP03/1/2010SLR24975016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf 3/5/2010
AP02/6/2012SLR31690017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021575s017lbl.pdf 2/6/2012
AP02/6/2012SLR31720017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020560s056,021575s017ltr.pdf 2/8/2012
AP03/1/2010SLR24976018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf 3/5/2010
AP03/1/2010SLR24886018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf 3/2/2010
AP01/25/2011SLR27609020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020lbl.pdf 1/26/2011
AP01/25/2011SLR27630020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s060,021575s020ltr.pdf 1/28/2011
AP07/1/2011SLR29416021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s061,021575s021ltr.pdf 7/6/2011
AP04/19/2013SLR35772022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s065,021575Orig1s022ltr.pdf 4/23/2013
AP04/19/2013SLR35806022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s065,021575s022lbl.pdf 4/23/2013
AP012/23/2013SLR38168023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s066,021575s023lbl.pdf 12/24/2013
AP012/23/2013SLR38183023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s066;021575Orig1s023ltr.pdf 12/26/2013
AP04/8/2015SLR42488024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf 4/10/2015
AP04/8/2015SLR42502024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s068,021575Orig1s024ltr.pdf 4/13/2015
AP011/30/2015SLR44632025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s069,021575Orig1s025ltr.pdf 12/1/2015
AP011/30/2015SLR44638025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s069,021575s025lbl.pdf 12/1/2015




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