Details for New Drug Application (NDA): 021035

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NDA 021035 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 021035

Tradename:	KEPPRA
Applicant:	Ucb Inc
Ingredient:	levetiracetam
Patents:	1

Pharmacology for NDA: 021035

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 021035

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KEPPRA	levetiracetam	TABLET;ORAL	021035	NDA	UCB, Inc.	50474-594	50474-594-40	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-594-40)
KEPPRA	levetiracetam	TABLET;ORAL	021035	NDA	UCB, Inc.	50474-595	50474-595-40	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-595-40)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Nov 30, 1999	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 7, 2031	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Nov 30, 1999	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 7, 2031	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Nov 30, 1999	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 7, 2031	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021035

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-002	Nov 30, 1999	⤷ Sign Up	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-004	Jan 6, 2006	⤷ Sign Up	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-001	Nov 30, 1999	⤷ Sign Up	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-003	Nov 30, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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