Treats hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets…. ANDA 90455, held by Onesource. Ergocalciferol.
As of Nov 15, 2026, ANDA 90455 (Ergocalciferol), held by Onesource, was first approved by FDA on Aug 3, 2010, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ergocalciferol50,000 IU · capsule;oral | Ergocalciferol | Rx |
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
