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MAGNESIUM SULFATE

ANDA

MAGNESIUM SULFATE | A217461 | SQUARE PHARMACEUTICALS PLC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MAGNESIUM SULFATE(TE code: AP)

API Supply Chain9 active DMFs2 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

JOST CHEMICAL COMAGNESIUM SULFATE DRIED

DMF 251332011

TOMITA PHARMACEUTICAL CO LTDMAGNESIUM SULFATE HEPTAHYDRATE

DMF 263012012

MACCO ORGANIQUES SROMAGNESIUM SULFATE HEPTAHYDRATE

DMF 311052016

MACCO ORGANIQUES SROMAGNESIUM SULFATE DRIED

DMF 318742017

AVANTOR PERFORMANCE MATERIALS LLCMAGNESIUM SULFATE ANHYDROUS

DMF 335712019

JOST CHEMICAL COMAGNESIUM SULFATE ANHYDROUS

DMF 341002020

GLOBAL CALCIUM PRIVATE LTDMAGNESIUM SULFATE USP

DMF 368732022

MAITHRI DRUGS PRIVATE LTDMAGNESIUM SULFATE DRIED USP

DMF 422362025

EMNAR PHARMA PRIVATE LTDMAGNESIUM SULFATE HEPTAHYDRATE

DMF 433422025

GILES CHEMICAL A DIVISION OF PREMIER MAGNESIA LLCInactiveMAGNESIUM SULFATE HEPTAHYDRATE, USP (PARENTERAL GRADES)

DMF 139601999

TOMITA PHARMACEUTICAL CO LTDInactiveMAGNESIUM SULFATE ANHYDROUS, USP

DMF 329312018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (4)

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#001 — 1GM/2ML (500MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Approved: Jul 9, 2026

No patent or exclusivity listings for this strength.

#002 — 5GM/10ML (500MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Approved: Jul 9, 2026

#003 — 10GM/20ML (500MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Approved: Jul 9, 2026

#004 — 25GM/50ML (500MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Approved: Jul 9, 2026