Controls severe or incapacitating allergic conditions. ANDA 214649, held by Aurobindo Pharma Ltd. Hydrocortisone.
As of Nov 14, 2026, ANDA 214649 (Hydrocortisone), held by Aurobindo Pharma Ltd, was first approved by FDA on Jul 17, 2023, with 2 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 |
|---|---|---|---|
| Jul 17, 2023 | Original application | Approved | None posted |
| Hydrocortisone5MG · tablet;oral | Hydrocortisone | Rx |
| Hydrocortisone10MG · tablet;oral | Hydrocortisone | Rx |
| Hydrocortisone20MG · tablet;oral | Hydrocortisone | Rx |
| Sep 5, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 11, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 17, 2023 | 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
