NDA 207926, held by Alcon. Phenylephrine Hydrochloride.
As of Nov 15, 2026, NDA 207926 (Phenylephrine Hydrochloride), held by Alcon, was first approved by FDA on Jan 15, 2015, with 2 approved supplements and 0 published complete response letters.
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 2015 | Original applicationTYPE 7 · Standard review | Approved |
| Phenylephrine Hydrochloride2.5% · solution/drops;ophthalmic | Phenylephrine Hydrochloride | RxReference drug |
| Phenylephrine Hydrochloride10% · solution/drops;ophthalmic | Phenylephrine Hydrochloride | RxReference drug |
| Mar 13, 2025 | Supplement 11Manufacturing | Approved | |
| Mar 1, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Jan 15, 2015 | Original applicationTYPE 7 · Standard review | Approved |
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
