NDA 9996, held by Pfizer. Prednisolone.
As of Nov 14, 2026, NDA 9996 (Sterane), held by Pfizer, was first approved by FDA on Jul 1, 1955, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 1955 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sterane5MG · tablet;oral | Prednisolone | Discontinued |
| Sep 17, 2001 | Supplement 5Labeling | Approved | None posted |
| Jul 1, 1955 | Original applicationNew formulation or manufacturer · Standard review | 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
