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Last Updated: March 28, 2024

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-four 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021035
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:RXDosage:TABLET;ORALStrength250MG
Approval Date:Nov 30, 1999TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Dec 7, 2031Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Nov 30, 1999TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Dec 7, 2031Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Nov 30, 1999TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Dec 7, 2031Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021035

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

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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.