Hectorol

NDA 21027, held by Sanofi. Doxercalciferol.

As of Nov 13, 2026, NDA 21027 (Hectorol), held by Sanofi, was first approved by FDA on Apr 6, 2000, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 6, 2000
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

Date	Submission	Status	Documents
Apr 6, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Hectorol4MCG/2ML (2MCG/ML) · injectable;injection	Doxercalciferol	DiscontinuedReference drug
Hectorol2MCG/ML (2MCG/ML) · injectable;injection	Doxercalciferol	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Sep 28, 2022	Supplement 38Labeling · Standard review	Approved	Label Letter
Nov 21, 2018	Supplement 34Labeling · Standard review	Approved	Letter Label
Jun 1, 2016	Supplement 26Labeling · Standard review	Approved	Letter Label
Dec 15, 2015	Supplement 31Manufacturing · Standard review	Approved	None posted
Sep 11, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Jul 31, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Dec 24, 2013	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 23, 2013	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 15, 2010	Supplement 21Manufacturing	Approved	None posted
Dec 5, 2008	Supplement 15Manufacturing · Standard review	Approved	Review Label Letter
Jul 20, 2006	Supplement 13Labeling · Standard review	Approved	Letter Label
Jun 22, 2005	Supplement 12Labeling · Standard review	Approved	Letter Label
Nov 26, 2003	Supplement 7Manufacturing · Standard review	Approved	Letter
Nov 19, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 24, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 3, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 26, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 6, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21027
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