Calcitriol

ANDA 75836, held by Fresenius Kabi USA. Calcitriol.

As of Nov 15, 2026, ANDA 75836 (Calcitriol), held by Fresenius Kabi USA, was first approved by FDA on Dec 31, 2002, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 31, 2002
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 31, 2002	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Nov 24, 2008	Supplement 5Labeling	Approved	None posted
Aug 6, 2003	Supplement 2Labeling	Approved	None posted
Dec 31, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75836
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi 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