ANDA 80568, held by Ferrante. Hydrocortisone.
As of Nov 13, 2026, ANDA 80568 (Hydrocortisone), held by Ferrante, was first approved by FDA on May 1, 1972, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 1972 | Original application | Approved | None posted |
| Hydrocortisone10MG · tablet;oral | Hydrocortisone | Discontinued |
| Hydrocortisone20MG · tablet;oral | Hydrocortisone | Discontinued |
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
