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FDA Drug Application 020560 by MERCK AND CO INC

Application Number020560
Application Type New Drug Application
Sponsor ApplicantMERCK AND CO INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/29/1995N18695000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 1/7/2008
AP09/29/1995N36006000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf 5/9/2013
AP010/16/1995SCS       
AP012/3/1996SLR       
AP04/25/1997SE14284003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20560ap_s03_s06.pdf 4/25/1997
AP011/21/1996SLR       
AP04/25/1997SE14285006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20560ap_s03_s06.pdf 4/25/1997
AP03/24/1997SCP       
AP01/27/1998SCP       
AP05/12/1998SLR       
AP06/16/1999SE1679012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560s12ltr.pdf 6/16/1999
AP06/16/1999SE1680012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S12_Fosamax.cfm 6/16/1999
AP06/16/1999SE1681012   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20560s12lbl.pdf 6/16/1999
AP06/8/1999SE8935013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax.cfm 6/8/1999
AP06/8/1999SE84722013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax_appltr.pdf 6/8/1999
AP06/8/1999SE84723013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax_prntlbl.pdf 6/8/1999
AP03/19/1999SLR20524014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S014_FOSAMAX TABLETS.pdf 8/8/2008
AP011/24/1999SE81032015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560S15LTR.PDF 11/24/1999
AP011/24/1999SE85549015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20560S15_fosamax.cfm 4/30/2003
AP010/19/1999SCP18540016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S016_FOSAMAX.pdf 11/19/2007
AP011/24/1999SE81206018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560S15LTR.PDF 11/24/1999
AP011/24/1999SE85548018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20560S18_fosamax.cfm 4/30/2003
AP05/28/1999SCM20523019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S019_FOSAMAX_TABLETS.pdf 8/8/2008
AP010/19/1999SCS18539020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S020_FOSAMAX.pdf 11/19/2007
AP010/20/2000SE21502021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20560S21ltr.pdf 10/20/2000
AP010/20/2000SE21963021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20560s21s22lbl.pdf 10/20/2000
AP010/20/2000SE21505022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20560S21ltr.pdf 10/20/2000
AP010/20/2000SE21964022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20560s21s22lbl.pdf 10/20/2000
AP09/29/2000SE11545023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S23ltr.pdf 9/29/2000
AP01/31/2001SLR1586024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20560LTR.pdf 1/31/2001
AP01/31/2001SLR1587024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20560lbl.pdf 1/31/2001
AP01/31/2001SE21588025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20560LTR.pdf 1/31/2001
AP01/31/2001SE21589025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20560lbl.pdf 1/31/2001
AP09/16/2002SLR1959028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20560slr028ltr.pdf 9/16/2002
AP09/16/2002SLR1960028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s28lbl.pdf 9/16/2002
AP09/16/2002SLR20442028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s028_FOSAMAX TABS.pdf 8/1/2008
AP06/26/2001SCM18538029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020560_S029_FOSAMAX.pdf 11/19/2007
AP04/27/2004SLR8447030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr030,21575slr002ltr.pdf 4/29/2004
AP04/27/2004SLR8485030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr030,21575slr002_fosamax_lbl.pdf 5/4/2004
AP07/25/2002SLR1958031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s31lbl.pdf 7/25/2002
AP07/25/2002SLR20441031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s031_FOSAMAX_TABLETS.pdf 8/1/2008
AP011/27/2001SCS20463032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020560_s032_FOSAMAX_TABLETS.pdf 8/4/2008
AP08/13/2002SCP1957033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20560scp033ltr.pdf 8/13/2002
AP08/13/2002SCP20440033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s033_FOSAMAX TABS.pdf 8/1/2008
AP08/5/2002SCP1955036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20560scp036ltr.pdf 8/5/2002
AP08/5/2002SCP1956036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s36lbl.pdf 8/5/2002
AP08/5/2002SCP20439036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s036_FOSAMAX_TABLETS.pdf 8/1/2008
AP03/24/2003SLR4502037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20560slr037ltr.pdf 3/26/2003
AP03/24/2003SLR20402037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020560_s037_FOSAMAX TABS.pdf 8/1/2008
AP012/21/2005SE113336038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020560s038_021575s007lbl.pdf 1/5/2006
AP012/21/2005SE113368038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s038,021575s007ltr.pdf 1/6/2006
AP09/17/2003SLR6686040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20560slr040_fosamax_lbl.pdf 9/25/2003
AP09/17/2003SLR6703040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20560slr040ltr.pdf 9/29/2003
AP04/16/2004SE88366041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560se8-041,21575slr004ltr.pdf 4/20/2004
AP04/16/2004SE88468041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560se8-041,21575slr004_fosamax_lbl.pdf 5/3/2004
AP04/16/2004SE820377041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020560_s041_FOSAMAX TABS.pdf 7/31/2008
AP02/20/2004SLR7797042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr042,21517slr003ltr.pdf 3/3/2004
AP02/20/2004SLR8197042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fosamax_lbl.pdf 4/5/2004
AP02/20/2004SLR17006042   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020560_S042 & 021575_S003_FOSAMAX_TABS_ORAL_SOLUTION_AP.pdf 7/6/2007
AP012/1/2004SLR10764043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf 12/8/2004
AP012/1/2004SLR10770043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf 12/8/2004
AP012/1/2004SLR10765044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf 12/8/2004
AP012/1/2004SLR10771044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf 12/8/2004
AP011/2/2005SLR13019046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021575s009,020560s046lbl.pdf 11/3/2005
AP011/2/2005SLR13037046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s046,021575s009ltr.pdf 11/8/2005
AP012/28/2006SLR15601047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf 1/8/2007
AP012/28/2006SLR15621047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf 1/8/2007
AP012/28/2006SLR15602048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf 1/8/2007
AP012/28/2006SLR15622048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf 1/8/2007
AP03/1/2010SLR24887051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf 3/2/2010
AP03/1/2010SLR24968051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf 3/5/2010
AP010/8/2008SCA20979052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020560s052, 021575s013, 021762s006ltr.pdf 10/9/2008
AP010/8/2008SCA21162052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf 11/7/2008
AP03/1/2010SLR24888055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf 3/2/2010
AP03/1/2010SLR24970055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf 3/5/2010
AP02/6/2012SLR31691056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s056lbl.pdf 2/6/2012
AP02/6/2012SLR31719056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020560s056,021575s017ltr.pdf 2/8/2012
AP03/1/2010SLR24889057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf 3/2/2010
AP03/1/2010SLR24972057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf 3/5/2010
AP01/25/2011SLR27608060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020MedG.pdf 1/26/2011
AP01/25/2011SLR27610060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020lbl.pdf 1/26/2011
AP01/25/2011SLR27629060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s060,021575s020ltr.pdf 1/28/2011
AP07/1/2011SLR29415061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s061,021575s021ltr.pdf 7/6/2011
AP06/27/2012SLR33043062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020560s062ltr.pdf 6/28/2012
AP06/27/2012SLR33047062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s062lbl.pdf 6/28/2012
AP06/27/2012SLR33048062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s062mg.pdf 6/28/2012
AP04/19/2013SLR35771065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s065,021575Orig1s022ltr.pdf 4/23/2013
AP04/19/2013SLR35807065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s065,021575s022lbl.pdf 4/23/2013
AP012/23/2013SLR38169066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s066,021575s023lbl.pdf 12/24/2013
AP012/23/2013SLR38182066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s066;021575Orig1s023ltr.pdf 12/26/2013
AP06/19/2015SCM       
AP04/8/2015SLR42489068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf 4/10/2015
AP04/8/2015SLR42498068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s068,021575Orig1s024ltr.pdf 4/13/2015
AP011/30/2015SLR44633069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s069,021575Orig1s025ltr.pdf 12/1/2015
AP011/30/2015SLR44637069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s069,021575s025lbl.pdf 12/1/2015




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