Hectorol

NDA 20862, held by Sanofi. Doxercalciferol.

As of Nov 14, 2026, NDA 20862 (Hectorol), held by Sanofi, was first approved by FDA on Jun 9, 1999, with 17 approved supplements and 0 published complete response letters.

First approved: Jun 9, 1999
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Jun 11, 2025	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 23, 2004	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 9, 1999	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Hectorol2.5MCG · capsule;oral	Doxercalciferol	DiscontinuedReference drug
Hectorol0.5MCG · capsule;oral	Doxercalciferol	DiscontinuedReference drug
Hectorol1MCG · capsule;oral	Doxercalciferol	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Jun 11, 2025	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 21, 2018	Supplement 31Labeling · Standard review	Approved	Letter Label
Jan 2, 2014	Supplement 32Manufacturing · Standard review	Approved	None posted
Feb 11, 2011	Supplement 30Labeling	Approved	Label Letter
Jul 13, 2009	Supplement 24Manufacturing	Approved	Label Letter
Jul 10, 2008	Supplement 23Manufacturing	Approved	Letter Label
Jul 20, 2006	Supplement 19Labeling · Standard review	Approved	Label Letter
Jun 24, 2005	Supplement 18Labeling · Standard review	Approved	Letter Label
Dec 17, 2004	Supplement 16Labeling · Standard review	Approved	Letter
Apr 23, 2004	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 19, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 24, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 17, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 3, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 26, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 25, 2001	Supplement 1Labeling · Standard review	Approved	None posted
May 30, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 9, 1999	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20862
Drugs@FDA: Overview at FDA
Company: Sanofi

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters