Magnesium Sulfate In Dextrose 5% In Plastic Container

Prevents eclampsia. ANDA 207349, held by Hq Spclt Pharma. Magnesium Sulfate.

As of Nov 15, 2026, ANDA 207349 (Magnesium Sulfate In Dextrose 5% In Plastic Container), held by Hq Spclt Pharma, was first approved by FDA on Mar 2, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 2, 2016
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Magnesium Sulfate in 5% Dextrose Injection, USP is indicated for:

Prevention of eclampsia in patients with preeclampsia
Treatment of seizures and prevention of recurrent seizures in patients with eclampsia

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 2, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Magnesium Sulfate In Dextrose 5% In Plastic Container1GM/100ML · injectable;injection	Magnesium Sulfate	Rx

All 4 submissions, including labeling and manufacturing supplements


Nov 27, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Nov 27, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Nov 25, 2016	Supplement 1Manufacturing	Approved	None posted
Mar 2, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 207349
Drugs@FDA: Overview at FDA
Company: HQ Specialty Pharma

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