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Generated: November 14, 2018

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Details for New Drug Application (NDA): 209911

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NDA 209911 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 209911
Tradename:MAGNESIUM SULFATE IN PLASTIC CONTAINER
Applicant:Mylan Labs Ltd
Ingredient:magnesium sulfate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/50ML (40MG/ML)
Approval Date:Sep 14, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4GM/100ML (40MG/ML)
Approval Date:Sep 14, 2018TE:APRLD:No

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