Details for New Drug Application (NDA): 022285

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NDA 022285 describes KEPPRA XR, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the KEPPRA XR profile page.

The generic ingredient in KEPPRA XR is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-seven suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

Summary for 022285

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

Pharmacology for NDA: 022285

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 022285

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285	NDA	UCB, Inc.	50474-598	50474-598-66	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-598-66)
KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285	NDA	UCB, Inc.	50474-599	50474-599-66	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-599-66)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Sep 12, 2008	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 17, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	750MG
Approval Date:	Feb 12, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 17, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022285

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-001	Sep 12, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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