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Generated: November 16, 2018

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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 two suppliers. 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. Ninety-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
Formulation / Manufacturing:see details
Pharmacology for NDA: 022285
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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Sep 12, 2008TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 17, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Feb 12, 2009TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 17, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022285

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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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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Dow
Queensland Health
Farmers Insurance
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Julphar

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