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Details for New Drug Application (NDA): 019316

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NDA 019316 describes MAGNESIUM SULFATE, which is a drug marketed by Hospira Inc, Fresenius Kabi Usa, Exela Pharma Scs Llc, Hospira, and Hq Spclt Pharma, and is included in nine NDAs. It is available from seven 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 twenty-eight drug master file entries for this compound. Eight suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the magnesium sulfate profile page.

Suppliers and Packaging for NDA: 019316

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAGNESIUM SULFATE
magnesium sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS 019316 NDA General Injectables and Vaccines, Inc. 52584-064 52584-064-02 1 VIAL, SINGLE-DOSE in 1 BAG (52584-064-02) > 2 mL in 1 VIAL, SINGLE-DOSE
MAGNESIUM SULFATE
magnesium sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS 019316 NDA Cardinal Health 55154-9358 55154-9358-5 5 VIAL, SINGLE-DOSE in 1 BAG (55154-9358-5) > 2 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, INTRAVENOUSStrength5GM/10ML (500MG/ML)
Approval Date:Sep 8, 1986TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, INTRAVENOUSStrength1GM/2ML (500MG/ML)
Approval Date:Sep 8, 1986TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, INTRAVENOUSStrength10GM/20ML (500MG/ML)
Approval Date:Jan 29, 2016TE:RLD:Yes


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