Doxercalciferol

ANDA 203929, held by Epic Pharma LLC. Doxercalciferol.

As of Nov 14, 2026, ANDA 203929 (Doxercalciferol), held by Epic Pharma LLC, was first approved by FDA on May 7, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: May 7, 2015
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
May 7, 2015	Original application	Approved	None posted

Products

2 strengths and forms


Doxercalciferol4MCG/2ML (2MCG/ML) · injectable;injection	Doxercalciferol	Discontinued
Doxercalciferol2MCG/ML (2MCG/ML) · injectable;injection	Doxercalciferol	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 14, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Oct 13, 2016	Supplement 4Labeling · Standard review	Approved	None posted
May 7, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203929
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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