ANDA 83140, held by Nexgen Pharma Inc. Hydrocortisone.
As of Nov 14, 2026, ANDA 83140 (Hydrocortisone), held by Nexgen Pharma Inc, was first approved by FDA on Mar 9, 1973, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 1973 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone20MG ยท 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
