Calderol

NDA 18312, held by Organon USA Inc. Calcifediol.

As of Nov 13, 2026, NDA 18312 (Calderol), held by Organon USA Inc, was first approved by FDA on Aug 5, 1980, with 7 approved supplements and 0 published complete response letters.

First approved: Aug 5, 1980
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Aug 5, 1980	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Calderol0.02MG · capsule;oral	Calcifediol	Discontinued
Calderol0.05MG · capsule;oral	Calcifediol	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 15, 2000	Supplement 12Labeling · Standard review	Approved	None posted
Dec 9, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 30, 1988	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 16, 1986	Supplement 8Labeling · Standard review	Approved	None posted
Jun 16, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 12, 1984	Supplement 4Labeling · Standard review	Approved	None posted
Aug 5, 1980	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18312
Drugs@FDA: Overview at FDA
Company: Organon USA

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