ANDA 212778, held by Upsher Smith Labs. Prednisolone Acetate.
As of Nov 15, 2026, ANDA 212778 (Prednisolone Acetate), held by Upsher Smith Labs, was first approved by FDA on Sep 28, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone Acetate1% ยท suspension/drops;ophthalmic | Prednisolone Acetate | Rx |
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
