Calcitriol

ANDA 76206, held by Rockwell Medcl. Calcitriol.

As of Nov 15, 2026, ANDA 76206 (Calcitriol), held by Rockwell Medcl, was first approved by FDA on Sep 17, 2003, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 17, 2003
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 17, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Calcitriol0.001MG/ML · injectable;injection	Calcitriol	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 17, 2014	Supplement 7Manufacturing	Approved	None posted
Sep 14, 2007	Supplement 6Labeling	Approved	None posted
Feb 23, 2007	Supplement 4Labeling	Approved	None posted
Sep 17, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76206
Drugs@FDA: Overview at FDA
Company: Rockwell Medical, Inc.

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