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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Deloitte
Medtronic
Dow
Teva
Moodys
Cerilliant
Cantor Fitzgerald
Merck

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021872

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NDA 021872 describes KEPPRA, which is a drug marketed by Ucb Inc and is included in four NDAs. It is available from six suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the KEPPRA profile page.

The generic ingredient in KEPPRA is levetiracetam. There are thirty-five drug master file entries for this compound. Ninety-five suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 021872
Tradename:KEPPRA
Applicant:Ucb Inc
Ingredient:levetiracetam
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 021872
Suppliers and Packaging for NDA: 021872
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KEPPRA levetiracetam INJECTABLE;IV (INFUSION) 021872 NDA UCB, Inc. 50474-002 N 50474-002-63
KEPPRA levetiracetam INJECTABLE;IV (INFUSION) 021872 NDA Cardinal Health 55154-7211 E 55154-7211-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength500MG/5ML (100MG/ML)
Approval Date:Jul 31, 2006TE:APRLD:Yes

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Federal Trade Commission
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