Doxercalciferol

ANDA 203875, held by Sun Pharm. Doxercalciferol.

As of Nov 14, 2026, ANDA 203875 (Doxercalciferol), held by Sun Pharm, was first approved by FDA on Nov 14, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 14, 2019
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
Nov 14, 2019	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


Dec 28, 2021	Supplement 4Manufacturing	Approved	None posted
Nov 14, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 203875
Drugs@FDA: Overview at FDA
Company: Sun 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