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Generated: January 19, 2019

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Details for New Drug Application (NDA): 207350

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NDA 207350 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 six 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-six 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 207350
Tradename:MAGNESIUM SULFATE IN PLASTIC CONTAINER
Applicant:Hq Spclt Pharma
Ingredient:magnesium sulfate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207350
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207350 ANDA WG Critical Care, LLC 44567-420 44567-420-24 24 POUCH in 1 CARTON (44567-420-24) > 1 BAG in 1 POUCH (44567-420-00) > 50 mL in 1 BAG
MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207350 ANDA WG Critical Care, LLC 44567-421 44567-421-24 24 POUCH in 1 CARTON (44567-421-24) > 1 BAG in 1 POUCH (44567-421-00) > 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/50ML (40MG/ML)
Approval Date:Dec 6, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4GM/100ML (40MG/ML)
Approval Date:Dec 6, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4GM/50ML (80MG/ML)
Approval Date:Dec 6, 2017TE:APRLD:No

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