Norepinephrine Bitartrate

For severe. ANDA 40455, held by Meitheal. Norepinephrine Bitartrate.

As of Nov 14, 2026, ANDA 40455 (Norepinephrine Bitartrate), held by Meitheal, was first approved by FDA on Mar 3, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 3, 2003
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Norepinephrine Bitartrate Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine Bitartrate Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 3, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Norepinephrine BitartrateEQ 1MG BASE/ML · injectable;injection	Norepinephrine Bitartrate	Rx

All 3 submissions, including labeling and manufacturing supplements


Sep 28, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Aug 31, 2015	Supplement 18Manufacturing	Approved	None posted
Mar 3, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40455
Drugs@FDA: Overview at FDA
Company: Meitheal Pharmaceuticals

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