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Generated: November 21, 2018

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Details for New Drug Application (NDA): 207349

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NDA 207349 describes MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, and Mylan Labs Ltd, and is included in four NDAs. It is available from three 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 drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.
Summary for 207349
Tradename:MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Hq Spclt Pharma
Ingredient:magnesium sulfate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207349
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 207349 ANDA WG Critical Care, LLC 44567-410 44567-410-24 24 BAG in 1 CARTON (44567-410-24) > 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/100ML
Approval Date:Mar 2, 2016TE:APRLD:No

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