NDA 020862

SANOFI

FDA Drug Application

Application #020862

Documents

• Letter: 2004-04-29
• Letter: 2004-12-30
• Letter: 2005-06-29
• Letter: 2008-07-14
• Letter: 2009-07-17
• Label: 2006-07-21
• Label: 2008-07-14
• Label: 2009-07-23
• Label: 2011-03-04
• Review: 1999-06-09
• Letter: 1999-06-09
• Letter: 2006-07-21
• Letter: 2011-02-15
• Label: 1999-06-09
• Label: 2004-05-04
• Label: 2005-06-29
• Label: 2018-11-23
• Letter: 2018-12-14

Application Sponsors

NDA 020862

SANOFI

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	2.5MCG	1	HECTOROL	DOXERCALCIFEROL
002	CAPSULE;ORAL	0.5MCG	1	HECTOROL	DOXERCALCIFEROL
003	CAPSULE;ORAL	1MCG	1	HECTOROL	DOXERCALCIFEROL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1999-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-06-26	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2004-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-06-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-06-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-11-19	STANDARD
LABELING; Labeling	SUPPL	16	AP	2004-12-17	STANDARD
LABELING; Labeling	SUPPL	18	AP	2005-06-24	STANDARD
LABELING; Labeling	SUPPL	19	AP	2006-07-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2008-07-10	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2009-07-13	N/A
LABELING; Labeling	SUPPL	30	AP	2011-02-11	UNKNOWN
LABELING; Labeling	SUPPL	31	AP	2018-11-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2014-01-02	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	30	Null	6
SUPPL	31	Null	6
SUPPL	32	Null	0

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SANOFI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20862
            [companyName] => SANOFI
            [docInserts] => ["",""]
            [products] => [{"drugName":"HECTOROL","activeIngredients":"DOXERCALCIFEROL","strength":"2.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"HECTOROL","activeIngredients":"DOXERCALCIFEROL","strength":"0.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"HECTOROL","activeIngredients":"DOXERCALCIFEROL","strength":"1MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/21\/2018","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020862s031,021027s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2011","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020862s030lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2009","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020862s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2009","submission":"SUPPL-24","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020862s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2008","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020862s023lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2008","submission":"SUPPL-23","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020862s023lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2006","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020862s019,021027s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/24\/2005","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020862s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2004","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20862se1-006_hectorol_lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20862lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HECTOROL","submission":"DOXERCALCIFEROL","actionType":"2.5MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"HECTOROL","submission":"DOXERCALCIFEROL","actionType":"0.5MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"HECTOROL","submission":"DOXERCALCIFEROL","actionType":"1MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-11-21
        )

)