Treats steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea…. ANDA 216935, held by Lupin. Prednisolone Acetate.
As of Nov 15, 2026, ANDA 216935 (Prednisolone Acetate), held by Lupin, was first approved by FDA on Aug 2, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Prednisolone acetate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone Acetate1% · 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
