NDA 20619, held by Alcon. Betaxolol Hydrochloride; Pilocarpine Hydrochloride.
As of Nov 14, 2026, NDA 20619 (Betoptic Pilo), held by Alcon, was first approved by FDA on Apr 17, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 17, 1997 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Betoptic PiloEQ 0.25% BASE;1.75% · suspension/drops;ophthalmic | Betaxolol Hydrochloride; Pilocarpine Hydrochloride | Discontinued |
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
