Calcitriol

ANDA 78066, held by Long Grove Pharms. Calcitriol.

As of Nov 15, 2026, ANDA 78066 (Calcitriol), held by Long Grove Pharms, was first approved by FDA on Jan 29, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 29, 2008
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 29, 2008	Original application	Approved	None posted

Products

2 strengths and forms


Calcitriol0.001MG/ML · injectable;injection	Calcitriol	Rx
Calcitriol0.002MG/ML · injectable;injection	Calcitriol	Discontinued

All 2 submissions, including labeling and manufacturing supplements


May 6, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Jan 29, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78066
Drugs@FDA: Overview at FDA
Company: Long Grove Pharmaceuticals

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