Controls severe or incapacitating allergic conditions. ANDA 207029, held by Strides Pharma. Hydrocortisone.
As of Nov 14, 2026, ANDA 207029 (Hydrocortisone), held by Strides Pharma, was first approved by FDA on Apr 27, 2017, with 3 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 |
|---|---|---|---|
| Apr 27, 2017 | Original application | Approved | None posted |
| Hydrocortisone5MG · tablet;oral | Hydrocortisone | Rx |
| Hydrocortisone10MG · tablet;oral | Hydrocortisone | Rx |
| Hydrocortisone20MG · tablet;oral | Hydrocortisone | Rx |
| Feb 3, 2025 | Supplement 19Labeling · Standard review | Approved | None posted |
| Jun 11, 2024 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jun 11, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 27, 2017 | 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
