NDA 12259, held by Pharmacia And Upjohn. Fluprednisolone.
As of Nov 13, 2026, NDA 12259 (Alphadrol), held by Pharmacia And Upjohn, was not approved, with 2 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Alphadrol1.5MG ยท tablet;oral | Fluprednisolone | Discontinued |
| Dec 7, 1982 | Supplement 18Labeling | Approved | None posted |
| Oct 24, 1978 | Supplement 17Labeling | 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