FDA.reportPublic FDA data

Application 021762

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSAMAX PLUS DALENDRONATE SODIUM; CHOLECALCIFEROLTABLET;ORALEQ 70MG BASE;2,800 IUYesNo
002FOSAMAX PLUS DALENDRONATE SODIUM; CHOLECALCIFEROLTABLET;ORALEQ 70MG BASE;5,600 IUYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0270FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLMerck Sharp & Dohme Corp.NDACurrent
0006-0270FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLMerck Sharp & Dohme Corp.NDACurrent
0006-0270FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLMerck Sharp & Dohme Corp.NDACurrent
0006-0270FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLMerck Sharp & Dohme Corp.NDACurrent
0006-0710FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLMerck Sharp & Dohme Corp.NDACurrent
0006-0710FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLMerck Sharp & Dohme Corp.NDACurrent
0006-0710FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLMerck Sharp & Dohme Corp.NDACurrent
0006-0710FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLMerck Sharp & Dohme Corp.NDACurrent
78206-136FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLOrganon LLCNDACurrent
78206-136FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLOrganon LLCNDACurrent
78206-136FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLOrganon LLCNDACurrent
78206-137FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLOrganon LLCNDACurrent
78206-137FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLOrganon LLCNDACurrent
78206-137FOSAMAX PLUS DALENDRONATE SODIUM and CHOLECALCIFEROLOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84931SUPPL 2026-02-05
84930SUPPL 2026-02-05
84914SUPPL 2026-02-05
59790SUPPL2019-08-21
59789SUPPL2019-08-21
59752SUPPL2019-08-20
37604SUPPL2015-12-02
6141SUPPL2015-12-01
6140SUPPL2015-04-13
16330SUPPL2015-04-10
37603SUPPL2013-11-08
28548SUPPL2013-11-08
23296ORIG2013-05-09
37602SUPPL2013-04-23
28547SUPPL2013-04-23
28546SUPPL2011-07-06
6139SUPPL2011-01-27
37601SUPPL2011-01-26
28545SUPPL2010-03-03
28544SUPPL2010-03-03
6138SUPPL2010-03-03
37600SUPPL2010-03-02
16329SUPPL2010-03-02
16327SUPPL2010-03-02
16328SUPPL2008-11-07
6137SUPPL2008-10-09
44150ORIG2008-01-07
28543SUPPL2007-05-01
16326SUPPL2007-05-01
37599SUPPL2007-01-08
37598SUPPL2007-01-08
6136SUPPL2007-01-08
6135SUPPL2007-01-08
21807ORIG2006-06-08
37597SUPPL2005-11-08
28542SUPPL2005-11-08
37596ORIG2005-04-12
28541ORIG2005-04-12