Treats presbyopia. ANDA 217733, held by Amneal. Pilocarpine Hydrochloride.
As of Nov 15, 2026, ANDA 217733 (Pilocarpine Hydrochloride), held by Amneal, was first approved by FDA on Apr 28, 2025, with 0 approved supplements and 0 published complete response letters.
Pilocarpine hydrochloride ophthalmic solution is indicated for the treatment of presbyopia in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pilocarpine Hydrochloride1.25% · solution/drops;ophthalmic | Pilocarpine Hydrochloride | 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
