Norepinephrine Bitartrate In 5% Dextrose, Norepinephrine Bitartrate In 0.9% Sodium Chloride

NDA 214313, held by Baxter Hlthcare Corp. Norepinephrine Bitartrate.

As of Nov 13, 2026, NDA 214313 (Norepinephrine Bitartrate In 5% Dextrose, Norepinephrine Bitartrate In 0.9% Sodium Chloride), held by Baxter Hlthcare Corp, was first approved by FDA on Jan 15, 2021, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 15, 2021
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 15, 2021	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

6 strengths and forms


Norepinephrine Bitartrate In 5% DextroseEQ 4MG BASE/250ML (EQ 16MCG BASE/ML) · solution;intravenous	Norepinephrine Bitartrate	RxReference drug
Norepinephrine Bitartrate In 5% DextroseEQ 8MG BASE/250ML (EQ 32MCG BASE/ML) · solution;intravenous	Norepinephrine Bitartrate	RxReference drug
Norepinephrine Bitartrate In 5% DextroseEQ 16MG BASE/250ML (EQ 64MCG BASE/ML) · solution;intravenous	Norepinephrine Bitartrate	RxReference drug
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

All 6 submissions, including labeling and manufacturing supplements


Feb 6, 2026	Supplement 8Manufacturing	Approved	Label Letter
Jun 11, 2024	Supplement 4Manufacturing	Approved	Letter
Nov 23, 2023	Supplement 3Manufacturing	Approved	Label Letter
Jun 2, 2022	Supplement 1Manufacturing	Approved	Letter
Jun 2, 2022	Supplement 2Manufacturing · Standard review	Approved	Label
Jan 15, 2021	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 214313
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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