Norepinephrine Bitartrate

ANDA 210839, held by Amneal. Norepinephrine Bitartrate.

As of Nov 15, 2026, ANDA 210839 (Norepinephrine Bitartrate), held by Amneal, was first approved by FDA on Dec 17, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 17, 2018
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 17, 2018	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Oct 30, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Dec 17, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210839
Drugs@FDA: Overview at FDA
Company: Amneal 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