NDA 11446, held by Pfizer. Prednisolone Acetate.
As of Nov 14, 2026, NDA 11446 (Sterane), held by Pfizer, was first approved by FDA on May 12, 1998, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 1998 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sterane25MG/ML · injectable;injection | Prednisolone Acetate | Discontinued |
| May 12, 1998 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| May 12, 1998 | Supplement 6Labeling | 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
