Calcitriol

ANDA 75746, held by Am Regent. Calcitriol.

As of Nov 15, 2026, ANDA 75746 (Calcitriol), held by Am Regent, was first approved by FDA on Sep 26, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 26, 2003
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
Sep 26, 2003	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 2 submissions, including labeling and manufacturing supplements


Jul 6, 2008	Supplement 3Labeling	Approved	None posted
Sep 26, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 75746
Drugs@FDA: Overview at FDA
Company: Am Regent

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