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Generated: April 25, 2017

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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 seven 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. There are two tentative approvals for this compound. Additional details are available on the levetiracetam profile page.

Summary for NDA: 021872

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
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
INJECTABLE;IV (INFUSION) 021872 NDA Cardinal Health 55154-7211 55154-7211-5 5 VIAL in 1 BAG (55154-7211-5) > 5 mL in 1 VIAL

Summary for product number 001

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

Expired Orange Book Patents for NDA: 021872

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
INJECTABLE;IV (INFUSION)021872-001Jul 31, 20064,943,639*PED► Subscribe
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