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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 202543


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NDA 202543 describes LEVETIRACETAM IN SODIUM CHLORIDE, which is a drug marketed by B Braun Medical Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, and Nexus, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the LEVETIRACETAM IN SODIUM CHLORIDE profile page.

The generic ingredient in LEVETIRACETAM IN SODIUM CHLORIDE is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 202543
Tradename:LEVETIRACETAM IN SODIUM CHLORIDE
Applicant:Hq Spclt Pharma
Ingredient:levetiracetam
Patents:0
Pharmacology for NDA: 202543
Suppliers and Packaging for NDA: 202543
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;INTRAVENOUS 202543 NDA WG Critical Care, LLC 44567-501 44567-501-10 10 BAG in 1 CARTON (44567-501-10) / 100 mL in 1 BAG (44567-501-01)
LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;INTRAVENOUS 202543 NDA WG Critical Care, LLC 44567-501 44567-501-90 10 BAG in 1 CARTON (44567-501-90) / 100 mL in 1 BAG (44567-501-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength500MG/100ML (5MG/ML)
Approval Date:Nov 9, 2011TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength1GM/100ML (10MG/ML)
Approval Date:Nov 9, 2011TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength1.5GM/100ML (15MG/ML)
Approval Date:Nov 9, 2011TE:APRLD:Yes

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