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Generated: November 22, 2018

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Details for New Drug Application (NDA): 206486

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NDA 206486 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 206486
Tradename:MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Fresenius Kabi Usa
Ingredient:magnesium sulfate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206486
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 206486 ANDA Fresenius Kabi USA, LLC 63323-108 63323-108-01 100 mL in 1 BAG (63323-108-01)
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 206486 ANDA Fresenius Kabi USA, LLC 63323-108 63323-108-26 100 mL in 1 BAG (63323-108-26)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/100ML
Approval Date:Mar 7, 2016TE:APRLD:No

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