Controls severe or incapacitating allergic conditions. ANDA 220329, held by Appco. Hydrocortisone.
As of Nov 14, 2026, ANDA 220329 (Hydrocortisone), held by Appco, was first approved by FDA on Feb 25, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND 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 |
|---|---|---|---|
| Feb 25, 2026 | 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
