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Generated: November 13, 2018

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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 four suppliers. 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. Ninety-seven 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 Rebel Distributors Corp 21695-070 21695-070-15 15 TABLET in 1 DRUM (21695-070-15)
KEPPRA levetiracetam TABLET;ORAL 021035 NDA UCB, Inc. 50474-594 50474-594-40 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-594-40)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Nov 30, 1999TE:ABRLD:Yes
Patent:➤ Try a Free 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 Free 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 Free 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 021035-003 Nov 30, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-004 Jan 6, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-002 Nov 30, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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