NDA 9127, held by Pfizer. Hydrocortisone.
As of Nov 13, 2026, NDA 9127 (Cortril), held by Pfizer, was first approved by FDA on Dec 3, 1953, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 3, 1953 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cortril20MG · tablet;oral | Hydrocortisone | Discontinued |
| Cortril10MG · 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