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DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090813

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Summary for NDA: 090813

Tradename:
LEVETIRACETAM
Applicant:
Fresenius Kabi Usa
Ingredient:
levetiracetam
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 090813

Suppliers and Packaging for NDA: 090813

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM
levetiracetam
INJECTABLE;IV (INFUSION) 090813 ANDA Nexus Pharmaceuticals Inc 14789-400 14789-400-05 10 VIAL in 1 CARTON (14789-400-05) > 5 mL in 1 VIAL
LEVETIRACETAM
levetiracetam
INJECTABLE;IV (INFUSION) 090813 ANDA Fresenius Kabi USA, LLC 63323-400 63323-400-05 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05) > 5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength500MG/5ML (100MG/ML)
Approval Date:May 26, 2010TE: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. thinkBiotech performs no independent verifification 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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