Doxercalciferol

ANDA 200926, held by Caplin. Doxercalciferol.

As of Nov 14, 2026, ANDA 200926 (Doxercalciferol), held by Caplin, was first approved by FDA on Feb 4, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 4, 2014
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
Feb 4, 2014	Original application	Approved	Letter

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Aug 22, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Oct 13, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Sep 4, 2014	Supplement 1Manufacturing	Approved	None posted
Feb 4, 2014	Original application	Approved	Letter

Identifiers

Application: ANDA 200926
Drugs@FDA: Overview at FDA
Company: Caplin Steriles

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