NDA 203510, held by Paragon Bioteck. Phenylephrine Hydrochloride.
As of Nov 13, 2026, NDA 203510 (Phenylephrine Hydrochloride), held by Paragon Bioteck, was first approved by FDA on Mar 21, 2013, with 3 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, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 21, 2013 | Original applicationTYPE 7 · Priority review | Approved |
| Phenylephrine Hydrochloride2.5% · solution/drops;ophthalmic | Phenylephrine Hydrochloride | RxReference drug |
| Phenylephrine Hydrochloride10% · solution/drops;ophthalmic | Phenylephrine Hydrochloride | RxReference drug |
| Dec 8, 2022 | Supplement 5Manufacturing · Standard review | Approved | |
| Apr 17, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Oct 8, 2013 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Mar 21, 2013 | Original applicationTYPE 7 · Priority 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
