Controls severe or incapacitating allergic conditions. ANDA 85070, held by Chartwell Molecular. Hydrocortisone.
As of Nov 13, 2026, ANDA 85070 (Hydrocortisone), held by Chartwell Molecular, was first approved by FDA on May 7, 1976, with 1 approved supplement 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 |
|---|---|---|---|
| May 7, 1976 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone20MG · tablet;oral | Hydrocortisone | Discontinued |
| Dec 17, 1990 | Supplement 4Labeling | Approved | None posted |
| May 7, 1976 | 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
