For severe. NDA 215700, held by Inforlife. Norepinephrine Bitartrate.
As of Nov 13, 2026, NDA 215700 (Norepinephrine Bitartrate In 0.9% Sodium Chloride), held by Inforlife, was first approved by FDA on Sep 15, 2022, with 3 approved supplements and 0 published complete response letters.
Norepinephrine Bitartrate in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine Bitartrate in Sodium Chloride Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2022 | Original applicationNew formulation or manufacturer · Standard review | 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 |
| Norepinephrine Bitartrate In 0.9% Sodium ChlorideEQ 32MG BASE/250ML (EQ 128MCG BASE/ML) · solution;intravenous | Norepinephrine Bitartrate | RxReference drug |
| Oct 15, 2025 | Supplement 12Manufacturing | Approved | |
| Jul 27, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Feb 6, 2023 | Supplement 1Labeling · Standard review | Approved | |
| Sep 15, 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
