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Last Updated: August 8, 2022

Details for New Drug Application (NDA): 020488

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NDA 020488 describes MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun Medical Inc, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, and Mylan Labs Ltd, and is included in six NDAs. It is available from six suppliers. Additional details are available on the MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER is magnesium sulfate. There are one hundred and forty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.
Summary for 020488
Ingredient:magnesium sulfate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 020488 NDA Hospira, Inc. 0409-6727 0409-6727-23 24 POUCH in 1 CASE (0409-6727-23) > 1 BAG in 1 POUCH > 100 mL in 1 BAG (0409-6727-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/100ML
Approval Date:Jul 11, 1995TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/100ML
Approval Date:Jul 11, 1995TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

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