Details for New Drug Application (NDA): 021505

✉ Email this page to a colleague

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-seven 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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505-001	Jul 15, 2003	⤷ Sign Up	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505-001	Jul 15, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.