Norepinephrine Bitartrate

For severe. ANDA 203662, held by Hikma. Norepinephrine Bitartrate.

As of Nov 15, 2026, ANDA 203662 (Norepinephrine Bitartrate), held by Hikma, was first approved by FDA on Nov 7, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 7, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Norepinephrine Bitartrate Injection, USP 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
Nov 7, 2018	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


Feb 26, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Feb 26, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Nov 7, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 203662
Drugs@FDA: Overview at FDA
Company: Hikma

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