NDA 215783, held by Inforlife. Phenylephrine Hydrochloride In Sodium Chloride.
As of Nov 13, 2026, NDA 215783 (Phenylephrine Hydrochloride In Sodium Chloride), held by Inforlife, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2026 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phenylephrine Hydrochloride In Sodium Chloride100MG/250ML 400MCG/ML · solution; injection | Phenylephrine Hydrochloride In Sodium Chloride | 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
