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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 207967


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NDA 207967 describes MAGNESIUM SULFATE, which is a drug marketed by B Braun Medical Inc, Exela Pharma, Fresenius Kabi Usa, Hospira, Baxter Hlthcare Corp, Hq Spclt Pharma, Mylan Labs Ltd, Amneal, Gland Pharma Ltd, and Milla Pharms, and is included in nineteen NDAs. It is available from eight suppliers. Additional details are available on the MAGNESIUM SULFATE profile page.

The generic ingredient in MAGNESIUM SULFATE is magnesium sulfate. There are one hundred and forty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.
Summary for 207967
Tradename:MAGNESIUM SULFATE
Applicant:B Braun Medical Inc
Ingredient:magnesium sulfate
Patents:0
Suppliers and Packaging for NDA: 207967
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAGNESIUM SULFATE magnesium sulfate INJECTABLE;INJECTION 207967 ANDA B. Braun Medical Inc. 0264-4204 0264-4204-52 24 CONTAINER in 1 CASE (0264-4204-52) / 50 mL in 1 CONTAINER
MAGNESIUM SULFATE magnesium sulfate INJECTABLE;INJECTION 207967 ANDA B. Braun Medical Inc. 0264-4205 0264-4205-52 24 CONTAINER in 1 CASE (0264-4205-52) / 50 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/50ML (40MG/ML)
Approval Date:Apr 26, 2021TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4GM/100ML (40MG/ML)
Approval Date:Apr 26, 2021TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4GM/50ML (80MG/ML)
Approval Date:Apr 26, 2021TE:APRLD:No

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