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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-four drug master file entries for this compound. Ninety suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the levetiracetam profile page.

Summary for NDA: 022285

Tradename:
KEPPRA XR
Applicant:
Ucb Inc
Ingredient:
levetiracetam
Patents:1
Therapeutic Class:Anticonvulsants
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Sep 12, 2008TE:ABRLD:No
Patent:7,858,122Patent Expiration:Sep 17, 2028Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Feb 12, 2009TE:ABRLD:Yes
Patent:7,858,122Patent Expiration:Sep 17, 2028Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022285

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
KEPPRA XR
levetiracetam
TABLET, EXTENDED RELEASE;ORAL022285-001Sep 12, 20084,943,639*PED► subscribe
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