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 one supplier. 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. Eighty-six 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

Pharmacology for NDA: 021872

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 021872

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	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:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	500MG/5ML (100MG/ML)
Approval Date:	Jul 31, 2006	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021872

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006	4,943,639*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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