For clinically important hypotension resulting primarily from vasodilation in the setting…. NDA 216830, held by Dr Reddys Labs SA. Phenylephrine Hydrochloride.
As of Nov 14, 2026, NDA 216830 (Phenylephrine Hydrochloride In 0.9% Sodium Chloride), held by Dr Reddys Labs SA, was first approved by FDA on May 30, 2025, with 0 approved supplements and 0 published complete response letters.
Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 30, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phenylephrine Hydrochloride In 0.9% Sodium Chloride20MG/250ML (0.08MG/ML) · solution;intravenous | Phenylephrine Hydrochloride | RxReference drug |
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
