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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 211356


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NDA 211356 describes LEVETIRACETAM IN SODIUM CHLORIDE, which is a drug marketed by B Braun Medical, Baxter Hlthcare Corp, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hq Spclt Pharma, and Nexus, and is included in nine NDAs. It is available from fourteen 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 211356
Tradename:LEVETIRACETAM IN SODIUM CHLORIDE
Applicant:Hikma
Ingredient:levetiracetam
Patents:0
Pharmacology for NDA: 211356
Physiological EffectDecreased Central Nervous System Disorganized Electrical Activity
Suppliers and Packaging for NDA: 211356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;INTRAVENOUS 211356 ANDA Hikma Pharmaceuticals USA Inc. 0143-9281 0143-9281-10 10 BAG in 1 BOX (0143-9281-10) / 100 mL in 1 BAG (0143-9281-01)
LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;INTRAVENOUS 211356 ANDA Hikma Pharmaceuticals USA Inc. 0143-9282 0143-9282-10 10 BAG in 1 BOX (0143-9282-10) / 100 mL in 1 BAG (0143-9282-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength500MG/100ML (5MG/ML)
Approval Date:Feb 12, 2024TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength1GM/100ML (10MG/ML)
Approval Date:Feb 12, 2024TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength1.5GM/100ML (15MG/ML)
Approval Date:Feb 12, 2024TE:APRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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