Doxercalciferol

ANDA 208974, held by Amneal. Doxercalciferol.

As of Nov 14, 2026, ANDA 208974 (Doxercalciferol), held by Amneal, was first approved by FDA on May 24, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: May 24, 2017
Review: Standard
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
May 24, 2017	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Aug 7, 2019	Supplement 3Labeling · Standard review	Approved	None posted
May 24, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 208974
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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