Magnesium Sulfate

ANDA 206039, held by Exela Pharma. Magnesium Sulfate.

As of Nov 15, 2026, ANDA 206039 (Magnesium Sulfate), held by Exela Pharma, was first approved by FDA on Dec 18, 2014, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 18, 2014
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 18, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Magnesium Sulfate5GM/10ML (500MG/ML) · solution;intramuscular, intravenous	Magnesium Sulfate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 27, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Dec 18, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 206039
Drugs@FDA: Overview at FDA
Company: Exela Pharma Sciences

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