Doxercalciferol

ANDA 91433, held by Hikma. Doxercalciferol.

As of Nov 14, 2026, ANDA 91433 (Doxercalciferol), held by Hikma, was first approved by FDA on Jan 14, 2014, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 14, 2014
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

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


Jan 14, 2014	Original application	Approved	None posted
Sep 23, 2011	Original application	Approved	Letter

Products

3 strengths and forms


Doxercalciferol0.5MCG · capsule;oral	Doxercalciferol	Discontinued
Doxercalciferol1MCG · capsule;oral	Doxercalciferol	Discontinued
Doxercalciferol2.5MCG · capsule;oral	Doxercalciferol	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Oct 2, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Jan 14, 2014	Original application	Approved	None posted
Sep 23, 2011	Original application	Approved	Letter

Identifiers

Application: ANDA 91433
Drugs@FDA: Overview at FDA
Company: Hikma

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