Treats hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets…. NDA 3444, held by Esjay Pharma. Ergocalciferol.
As of Nov 14, 2026, NDA 3444 (Drisdol), held by Esjay Pharma, was first approved by FDA on Jan 11, 1941, with 14 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 1941 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Drisdol50,000 IU · capsule;oral | Ergocalciferol | RxReference drug |
| Nov 20, 2003 | Supplement 20Labeling · Standard review | Approved | |
| Apr 3, 1992 | Supplement 19Manufacturing | Approved | None posted |
| Mar 14, 1990 | Supplement 18Manufacturing | Approved | None posted |
| Sep 14, 1988 | Supplement 17Manufacturing | Approved | None posted |
| Apr 17, 1986 | Supplement 16Labeling | Approved | None posted |
| Mar 11, 1985 | Supplement 15Labeling | Approved | None posted |
| Mar 11, 1985 | Supplement 13Labeling | Approved | None posted |
| Jul 7, 1980 | Supplement 12Labeling | Approved | None posted |
| Jan 19, 1978 | Supplement 10Labeling | Approved | None posted |
| Dec 7, 1976 | Supplement 9Labeling | Approved | None posted |
| Dec 7, 1976 | Supplement 8Labeling | Approved | None posted |
| Jun 22, 1976 | Supplement 7Labeling | Approved | None posted |
| Mar 4, 1976 | Supplement 6Manufacturing | Approved | None posted |
| Jun 19, 1975 | Supplement 5Labeling | Approved | None posted |
| Jan 11, 1941 | Original application | Approved | None posted |
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
