Details for New Drug Application (NDA): 021505

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NDA 021505 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 021505

Tradename:	KEPPRA
Applicant:	Ucb Inc
Ingredient:	levetiracetam
Patents:	0

Pharmacology for NDA: 021505

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 021505

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KEPPRA	levetiracetam	SOLUTION;ORAL	021505	NDA	UCB, Inc.	50474-001	50474-001-48	473 mL in 1 BOTTLE, PLASTIC (50474-001-48)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	100MG/ML
Approval Date:	Jul 15, 2003	TE:	AA	RLD:	Yes

Expired US Patents for NDA 021505

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505-001	Jul 15, 2003	4,837,223	⤷ Subscribe
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505-001	Jul 15, 2003	4,943,639*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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