MERCK AND CO INC FDA Approval NDA 020560

NDA 020560

MERCK AND CO INC

FDA Drug Application

Application #020560

Documents

Letter1999-06-08
Letter1999-11-24
Letter1999-11-24
Letter2000-10-20
Letter2001-01-31
Letter2002-09-16
Letter2002-08-05
Letter2004-03-03
Letter2004-12-08
Letter2005-11-08
Letter2007-01-08
Letter2010-03-05
Letter2012-02-08
Letter2015-12-01
Label1999-06-08
Label2000-10-20
Label2004-05-04
Label2004-05-03
Label2004-04-05
Label2004-12-08
Label2005-11-03
Label2007-01-08
Label2010-03-02
Label2012-02-06
Label2013-04-23
Review1997-04-25
Review1999-06-08
Review2003-04-30
Review2003-04-30
Review2007-11-19
Review2008-08-01
Review2008-08-01
Review2008-08-04
Review2008-08-01
Review2008-08-01
Review2008-08-01
Review2007-07-06
Medication Guide2013-05-09
Letter1999-06-16
Letter2000-10-20
Letter2000-09-29
Letter2001-01-31
Letter2004-04-29
Letter2002-08-13
Letter2003-03-26
Letter2006-01-06
Letter2003-09-29
Letter2004-04-20
Letter2004-12-08
Letter2007-01-08
Letter2010-03-05
Letter2008-10-09
Letter2010-03-05
Letter2011-01-28
Letter2011-07-06
Letter2012-06-28
Letter2013-04-23
Letter2013-12-26
Letter2015-04-13
Label1999-06-16
Label2000-10-20
Label2001-01-31
Label2001-01-31
Label2002-09-16
Label2002-07-25
Label2002-08-05
Label2006-01-05
Label2003-09-25
Label2004-12-08
Label2007-01-08
Label2008-11-07
Label2010-03-02
Label2010-03-02
Label2011-01-26
Label2012-06-28
Label2013-12-24
Label2015-04-10
Label2015-12-01
Review1997-04-25
Review1999-06-16
Review2008-08-08
Review2007-11-19
Review2008-08-08
Review2007-11-19
Review2008-07-31
Other Important Information from FDA2008-01-07
Pediatric Written Request1900-01-01
Pediatric Reissue Amendment 11900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Medication Guide2018-11-08
Review2019-02-15
Letter2019-08-20
Label2019-08-21

Application Sponsors

NDA 020560MERCK AND CO INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Prescription005

Application Products

001TABLET;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1FOSAMAXALENDRONATE SODIUM
002TABLET;ORALEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1FOSAMAXALENDRONATE SODIUM
003TABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1FOSAMAXALENDRONATE SODIUM
004TABLET;ORALEQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1FOSAMAXALENDRONATE SODIUM
005TABLET;ORALEQ 70MG BASE1FOSAMAXALENDRONATE SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1995-09-29PRIORITY
LABELING; LabelingSUPPL2AP1996-12-03STANDARD
EFFICACY; EfficacySUPPL3AP1997-04-25STANDARD
LABELING; LabelingSUPPL5AP1996-11-21
EFFICACY; EfficacySUPPL6AP1997-04-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1997-03-24PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1998-01-27PRIORITY
LABELING; LabelingSUPPL11AP1998-05-12STANDARD
EFFICACY; EfficacySUPPL12AP1999-06-16STANDARD
EFFICACY; EfficacySUPPL13AP1999-06-08STANDARD
LABELING; LabelingSUPPL14AP1999-03-19STANDARD
EFFICACY; EfficacySUPPL15AP1999-11-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1999-10-19PRIORITY
EFFICACY; EfficacySUPPL18AP1999-11-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1999-05-28PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1999-10-19PRIORITY
EFFICACY; EfficacySUPPL21AP2000-10-20UNKNOWN
EFFICACY; EfficacySUPPL22AP2000-10-20UNKNOWN
EFFICACY; EfficacySUPPL23AP2000-09-29STANDARD
LABELING; LabelingSUPPL24AP2001-01-31STANDARD
EFFICACY; EfficacySUPPL25AP2001-01-31STANDARD
LABELING; LabelingSUPPL28AP2002-09-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2001-06-26PRIORITY
LABELING; LabelingSUPPL30AP2004-04-27STANDARD
LABELING; LabelingSUPPL31AP2002-07-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2001-11-27PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL33AP2002-08-13PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL36AP2002-08-05PRIORITY
LABELING; LabelingSUPPL37AP2003-03-24STANDARD
EFFICACY; EfficacySUPPL38AP2005-12-21PRIORITY
LABELING; LabelingSUPPL40AP2003-09-17STANDARD
EFFICACY; EfficacySUPPL41AP2004-04-16UNKNOWN
LABELING; LabelingSUPPL42AP2004-02-20STANDARD
LABELING; LabelingSUPPL43AP2004-12-01STANDARD
LABELING; LabelingSUPPL44AP2004-12-01STANDARD
LABELING; LabelingSUPPL46AP2005-11-02STANDARD
LABELING; LabelingSUPPL47AP2006-12-28STANDARD
LABELING; LabelingSUPPL48AP2006-12-28STANDARD
LABELING; LabelingSUPPL51AP2010-03-01STANDARD
LABELING; LabelingSUPPL52AP2008-10-08STANDARD
LABELING; LabelingSUPPL55AP2010-03-01STANDARD
LABELING; LabelingSUPPL56AP2012-02-06STANDARD
LABELING; LabelingSUPPL57AP2010-03-01STANDARD
REMS; REMSSUPPL60AP2011-01-25N/A
REMS; REMSSUPPL61AP2011-07-01N/A
LABELING; LabelingSUPPL62AP2012-06-27UNKNOWN
LABELING; LabelingSUPPL65AP2013-04-19STANDARD
LABELING; LabelingSUPPL66AP2013-12-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL67AP2015-06-19PRIORITY
LABELING; LabelingSUPPL68AP2015-04-08STANDARD
LABELING; LabelingSUPPL69AP2015-11-30STANDARD
LABELING; LabelingSUPPL70AP2019-08-16STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL7Null0
SUPPL10Null0
SUPPL16Null0
SUPPL19Null0
SUPPL20Null0
SUPPL29Null0
SUPPL32Null0
SUPPL33Null0
SUPPL36Null0
SUPPL38Null8
SUPPL51Null6
SUPPL55Null6
SUPPL56Null6
SUPPL57Null6
SUPPL60Null6
SUPPL61Null6
SUPPL62Null6
SUPPL65Null7
SUPPL66Null15
SUPPL67Null0
SUPPL68Null15
SUPPL69Null6
SUPPL70Null6

TE Codes

005PrescriptionAB

CDER Filings

MERCK AND CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20560
            [companyName] => MERCK AND CO INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2015\/020560s068,021575s024lbl.pdf#page=24"]
            [products] => [{"drugName":"FOSAMAX","activeIngredients":"ALENDRONATE SODIUM","strength":"EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"FOSAMAX","activeIngredients":"ALENDRONATE SODIUM","strength":"EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"FOSAMAX","activeIngredients":"ALENDRONATE SODIUM","strength":"EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"FOSAMAX","activeIngredients":"ALENDRONATE SODIUM","strength":"EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"FOSAMAX","activeIngredients":"ALENDRONATE SODIUM","strength":"EQ 70MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/16\/2019","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020560s070lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2015","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020560s069,021575s025lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2015","submission":"SUPPL-68","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020560s068,021575s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2013","submission":"SUPPL-66","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020560s062lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2012","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020560s056lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2011","submission":"SUPPL-60","supplementCategories":"REMS","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020560s060,021575s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2010","submission":"SUPPL-57","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020560s051s055s057,021575s012s016s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2010","submission":"SUPPL-55","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020560s051s055s057,021575s012s016s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2010","submission":"SUPPL-51","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020560s051s055s057,021575s012s016s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2008","submission":"SUPPL-52","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020560s052,021575s013,021762s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2006","submission":"SUPPL-48","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020560s47s48,021575s10s11,021762s2s3lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2006","submission":"SUPPL-47","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020560s47s48,021575s10s11,021762s2s3lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2005","submission":"SUPPL-38","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020560s038_021575s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2005","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021575s009,020560s046lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2004","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20560s043,044,21575s005,006lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2004","submission":"SUPPL-43","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20560s043,044,21575s005,006lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2004","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20560slr030,21575slr002_fosamax_lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2004","submission":"SUPPL-41","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20560se8-041,21575slr004_fosamax_lbl.pdf\"}]","notes":""},{"actionDate":"02\/20\/2004","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20560slr042,21517slr003_fosamax_lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2003","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20560slr040_fosamax_lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2002","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20560s28lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2002","submission":"SUPPL-36","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20560s36lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2002","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20560s31lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2001","submission":"SUPPL-25","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20560lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2001","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20560lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2000","submission":"SUPPL-22","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20560s21s22lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2000","submission":"SUPPL-21","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20560s21s22lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/1999","submission":"SUPPL-12","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20560s12lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/1999","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/020560S13_Fosamax_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FOSAMAX","submission":"ALENDRONATE SODIUM","actionType":"EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"FOSAMAX","submission":"ALENDRONATE SODIUM","actionType":"EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"FOSAMAX","submission":"ALENDRONATE SODIUM","actionType":"EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"FOSAMAX","submission":"ALENDRONATE SODIUM","actionType":"EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"FOSAMAX","submission":"ALENDRONATE SODIUM","actionType":"EQ 70MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-08-16
        )

)
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