For severe. NDA 214628, held by Long Grove Pharms. Norepinephrine Bitartrate.
As of Nov 14, 2026, NDA 214628 (Norepinephrine Bitartrate In 0.9% Sodium Chloride), held by Long Grove Pharms, was first approved by FDA on Oct 6, 2022, with 1 approved supplement and 1 published complete response letter.
Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine in Sodium Chloride Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jun 14, 2021 | Norepinephrine Bitartrate in Sodium ChlorideFacility Inspections | Approved |
| Norepinephrine Bitartrate In 0.9% Sodium ChlorideEQ 4MG BASE/250ML (EQ 16MCG BASE/ML) · solution;intravenous | Norepinephrine Bitartrate | RxReference drug |
| Norepinephrine Bitartrate In 0.9% Sodium ChlorideEQ 8MG BASE/250ML (EQ 32MCG BASE/ML) · solution;intravenous | Norepinephrine Bitartrate | RxReference drug |
| Norepinephrine Bitartrate In 0.9% Sodium ChlorideEQ 16MG BASE/250ML (EQ 64MCG BASE/ML) · solution;intravenous | Norepinephrine Bitartrate | RxReference drug |
| Dec 3, 2024 | Supplement 4Manufacturing | Approved | |
| Oct 6, 2022 | Original applicationNew formulation or manufacturer · 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
