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Generated: January 19, 2019

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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 four 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-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 021872
Applicant:Ucb Inc
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 50474-002-63 10 VIAL, SINGLE-USE in 1 CARTON (50474-002-63) > 5 mL in 1 VIAL, SINGLE-USE

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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