Controls severe or incapacitating allergic conditions. ANDA 217881, held by Novitium Pharma. Hydrocortisone.
As of Nov 13, 2026, ANDA 217881 (Hydrocortisone), held by Novitium Pharma, was first approved by FDA on May 2, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 2, 2025 | Original application | Approved | None posted |
| Hydrocortisone5MG · tablet;oral | Hydrocortisone | Rx |
| Hydrocortisone10MG · tablet;oral | Hydrocortisone | Rx |
| Hydrocortisone20MG · tablet;oral | Hydrocortisone | 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
