FDA.reportPublic FDA data

Application 020560

Type
NDA
Sponsor
MERCK AND CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSAMAXALENDRONATE SODIUMTABLET;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002FOSAMAXALENDRONATE SODIUMTABLET;ORALEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003FOSAMAXALENDRONATE SODIUMTABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004FOSAMAXALENDRONATE SODIUMTABLET;ORALEQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005FOSAMAXALENDRONATE SODIUMTABLET;ORALEQ 70MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0031FOSAMAXalendronate sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-0031FOSAMAXalendronate sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-0031FOSAMAXalendronate sodiumMerck Sharp & Dohme Corp.NDACurrent
78206-135FOSAMAXalendronate sodiumOrganon LLCNDACurrent
78206-135FOSAMAXalendronate sodiumOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84928SUPPL 2026-02-05
84927SUPPL 2026-02-05
84912SUPPL 2026-02-05
59795SUPPL2019-08-21
59756SUPPL2019-08-20
57661ORIG2019-02-15
56350SUPPL2018-11-08
34838SUPPL2015-12-01
2731SUPPL2015-12-01
25183SUPPL2015-04-13
34837SUPPL2015-04-10
25182SUPPL2013-12-26
34836SUPPL2013-12-24
23163ORIG2013-05-09
25181SUPPL2013-04-23
12730SUPPL2013-04-23
34835SUPPL2012-06-28
25180SUPPL2012-06-28
2730SUPPL2012-02-08
12729SUPPL2012-02-06
25179SUPPL2011-07-06
25178SUPPL2011-01-28
34834SUPPL2011-01-26
25177SUPPL2010-03-05
25175SUPPL2010-03-05
2729SUPPL2010-03-05
34833SUPPL2010-03-02
34832SUPPL2010-03-02
12728SUPPL2010-03-02
34831SUPPL2008-11-07
25176SUPPL2008-10-09
41430SUPPL2008-08-08
41428SUPPL2008-08-08
20725SUPPL2008-08-04
20728SUPPL2008-08-01
20727SUPPL2008-08-01
20726SUPPL2008-08-01
20724SUPPL2008-08-01
20723SUPPL2008-08-01
41432SUPPL2008-07-31
44058ORIG2008-01-07
41431SUPPL2007-11-19
41429SUPPL2007-11-19
20722SUPPL2007-11-19
20729SUPPL2007-07-06
34830SUPPL2007-01-08
25174SUPPL2007-01-08
12727SUPPL2007-01-08
2728SUPPL2007-01-08
25170SUPPL2006-01-06
34827SUPPL2006-01-05
2727SUPPL2005-11-08
12726SUPPL2005-11-03
34829SUPPL2004-12-08
25173SUPPL2004-12-08
12725SUPPL2004-12-08
2726SUPPL2004-12-08
12722SUPPL2004-05-04
12723SUPPL2004-05-03
25167SUPPL2004-04-29
25172SUPPL2004-04-20
12724SUPPL2004-04-05
2725SUPPL2004-03-03
25171SUPPL2003-09-29
34828SUPPL2003-09-25
20721SUPPL2003-04-30
20720SUPPL2003-04-30
25169SUPPL2003-03-26
34824SUPPL2002-09-16
2723SUPPL2002-09-16
25168SUPPL2002-08-13
34826SUPPL2002-08-05
2724SUPPL2002-08-05
34825SUPPL2002-07-25
34823SUPPL2001-01-31
34822SUPPL2001-01-31
25166SUPPL2001-01-31
2722SUPPL2001-01-31
34821SUPPL2000-10-20
25164SUPPL2000-10-20
12721SUPPL2000-10-20
2721SUPPL2000-10-20
25165SUPPL2000-09-29
2720SUPPL1999-11-24
2719SUPPL1999-11-24
41427SUPPL1999-06-16
34820SUPPL1999-06-16
25163SUPPL1999-06-16
20719SUPPL1999-06-08
12720SUPPL1999-06-08
2718SUPPL1999-06-08
41426SUPPL1997-04-25
20718SUPPL1997-04-25
51765ORIG1900-01-01
51764ORIG1900-01-01
51763ORIG1900-01-01
51762ORIG1900-01-01
51761ORIG1900-01-01