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Generated: November 20, 2018

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Details for New Drug Application (NDA): 206485

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NDA 206485 describes MAGNESIUM SULFATE 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 five suppliers. Additional details are available on the MAGNESIUM SULFATE IN PLASTIC CONTAINER profile page.

The generic ingredient in MAGNESIUM SULFATE 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 206485
Tradename:MAGNESIUM SULFATE IN PLASTIC CONTAINER
Applicant:Fresenius Kabi Usa
Ingredient:magnesium sulfate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206485
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 206485 ANDA A-S Medication Solutions 50090-3323 50090-3323-0 50 mL in 1 BAG (50090-3323-0)
MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 206485 ANDA Fresenius Kabi USA, LLC 63323-106 63323-106-26 50 mL in 1 BAG (63323-106-26)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4GM/100ML (40MG/ML)
Approval Date:Mar 15, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4GM/50ML (80MG/ML)
Approval Date:Mar 15, 2016TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/50ML (40MG/ML)
Approval Date:Mar 15, 2016TE:APRLD:No

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