Doxercalciferol

Sold as Hectorol, Doxercalciferol. Every FDA application for this active ingredient: 3 branded and 16 generic.

As of Nov 14, 2026, FDA lists 19 applications for Doxercalciferol (sold as Hectorol, Doxercalciferol), first approved Jun 9, 1999, with 2 new uses approved and 0 published complete response letters.

First approved: Jun 9, 1999
Applications: 19
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $573K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Doxercalciferol	Part D	$572K	-7%	299
Doxercalciferol	Part B	$0K	+614%	0

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Comparative Effects of Doxercalciferol and Calcitriol on Secondary Hyperparathyroidism in ESRDLowering Parathyroid Hormone Level in Patients on Hemodioalysis · Chittagong Medical College	Not applicable	Not yet recruiting	Jun 10, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 9, 1999	HectorolNDA 20862 · New molecular entity	Sanofi	17	Discontinued
Apr 6, 2000	HectorolNDA 21027 · New dosage form	Sanofi	17	Discontinued
Aug 30, 2013	DoxercalciferolANDA 91101	Hikma	0	Discontinued
Jan 14, 2014	DoxercalciferolANDA 91433	Hikma	2	Discontinued
Feb 4, 2014	DoxercalciferolANDA 200926	Caplin	3	Discontinued
May 5, 2014	DoxercalciferolANDA 91333	Sandoz	1	Marketed
May 7, 2015	DoxercalciferolANDA 203929	Epic Pharma LLC	2	Discontinued
Sep 9, 2016	DoxercalciferolANDA 201518	Rising	1	Marketed
May 24, 2017	DoxercalciferolANDA 208974	Amneal	1	Discontinued
May 24, 2017	DoxercalciferolANDA 208975	Amneal	1	Discontinued
Jul 24, 2018	DoxercalciferolNDA 208614 · New formulation or manufacturer	Hospira	1	Discontinued
Nov 1, 2018	DoxercalciferolANDA 210801	Lupin	0	Discontinued
Sep 26, 2019	DoxercalciferolANDA 210452	Gland	0	Marketed
Nov 14, 2019	DoxercalciferolANDA 203875	Sun Pharm	1	Discontinued
Feb 7, 2020	DoxercalciferolANDA 211670	Meitheal	0	Marketed
Sep 15, 2020	DoxercalciferolANDA 205360	Avet	0	Marketed
Jan 24, 2022	DoxercalciferolANDA 213717	Eugia Pharma	0	Discontinued
Jun 15, 2023	DoxercalciferolANDA 215810	Alembic	0	Marketed
—	DoxercalciferolANDA 90040	Cobrek Pharma	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA