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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 seven 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-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: 021035

Tradename:
KEPPRA
Applicant:
Ucb Inc
Ingredient:
levetiracetam
Patents:1
Therapeutic Class:Anticonvulsants
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 STAT RX USA LLC 16590-134 16590-134-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-134-30)
KEPPRA
levetiracetam
TABLET;ORAL 021035 NDA STAT RX USA LLC 16590-135 16590-135-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-135-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Nov 30, 1999TE:ABRLD:No
Patent:8,802,142*PEDPatent Expiration:Dec 7, 2031Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Nov 30, 1999TE:ABRLD:No
Patent:8,802,142*PEDPatent Expiration:Dec 7, 2031Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Nov 30, 1999TE:ABRLD:No
Patent:8,802,142*PEDPatent Expiration:Dec 7, 2031Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021035

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-004Jan 6, 20064,943,639*PED► subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-002Nov 30, 19994,943,639*PED► subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-003Nov 30, 19994,943,639*PED► subscribe
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