Vitamin D

Treats hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets…. ANDA 80704, held by Bionpharma. Ergocalciferol.

As of Nov 15, 2026, ANDA 80704 (Vitamin D), held by Bionpharma, was first approved by FDA on Oct 16, 1978, with 25 approved supplements and 0 published complete response letters.

First approved: Oct 16, 1978
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Oct 16, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vitamin D50,000 IU · capsule;oral	Ergocalciferol	Rx

All 26 submissions, including labeling and manufacturing supplements


Jul 24, 2008	Supplement 43Labeling	Approved	None posted
Oct 24, 2001	Supplement 41Labeling	Approved	None posted
Oct 24, 2001	Supplement 40Manufacturing	Approved	None posted
Oct 24, 2001	Supplement 39Manufacturing	Approved	None posted
Oct 24, 2001	Supplement 38Manufacturing	Approved	None posted
Oct 24, 2001	Supplement 37Manufacturing	Approved	None posted
Sep 9, 1998	Supplement 36Manufacturing	Approved	None posted
Jan 16, 1997	Supplement 30Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 34Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 33Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 32Manufacturing	Approved	None posted
May 31, 1995	Supplement 31Manufacturing	Approved	None posted
Jan 24, 1995	Supplement 29Manufacturing	Approved	None posted
Jan 24, 1995	Supplement 28Manufacturing	Approved	None posted
Mar 24, 1989	Supplement 27Labeling	Approved	None posted
Mar 22, 1985	Supplement 23Manufacturing	Approved	None posted
Mar 22, 1985	Supplement 22Manufacturing	Approved	None posted
Mar 22, 1985	Supplement 21Manufacturing	Approved	None posted
Mar 22, 1985	Supplement 20Manufacturing	Approved	None posted
Mar 22, 1985	Supplement 19Manufacturing	Approved	None posted
Mar 22, 1985	Supplement 18Manufacturing	Approved	None posted
Mar 22, 1985	Supplement 17Manufacturing	Approved	None posted
Mar 22, 1985	Supplement 16Manufacturing	Approved	None posted
Mar 22, 1985	Supplement 15Manufacturing	Approved	None posted
Mar 8, 1984	Supplement 12Manufacturing	Approved	None posted
Oct 16, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 80704
Drugs@FDA: Overview at FDA
Company: Bionpharma

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