Doxercalciferol

ANDA 91333, held by Sandoz. Doxercalciferol.

As of Nov 14, 2026, ANDA 91333 (Doxercalciferol), held by Sandoz, was first approved by FDA on May 5, 2014, with 1 approved supplement and 0 published complete response letters.

First approved: May 5, 2014
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 5, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Doxercalciferol4MCG/2ML (2MCG/ML) · injectable;injection	Doxercalciferol	Rx

All 2 submissions, including labeling and manufacturing supplements


Nov 14, 2016	Supplement 1Labeling · Standard review	Approved	None posted
May 5, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 91333
Drugs@FDA: Overview at FDA
Company: Sandoz

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