Controls severe or incapacitating allergic conditions. ANDA 40646, held by Impax Labs Inc. Hydrocortisone.
As of Nov 13, 2026, ANDA 40646 (Hydrocortisone), held by Impax Labs Inc, was first approved by FDA on Mar 30, 2007, with 4 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 |
|---|---|---|---|
| Mar 30, 2007 | Original application | Approved | None posted |
| Hydrocortisone5MG · tablet;oral | Hydrocortisone | Rx |
| Hydrocortisone10MG · tablet;oral | Hydrocortisone | Rx |
| Hydrocortisone20MG · tablet;oral | Hydrocortisone | Rx |
| Sep 25, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 25, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 21, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 21, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 30, 2007 | 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
