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Orange Book product · Brand (NDA)

KEPPRA

LEVETIRACETAM

Brand (NDA)NDA 021035TE ABRX UCB INC
View LEVETIRACETAM familyOpen on FDA Orange Book

At a glance

Jan 06, 2006

Approved

Brand (NDA)

Application

AB

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 06, 2006

    20 yr 9 mo ago

  2. Today

  3. Patent 8802142 expires

    Listed drug product patent expiration.

    Jun 07, 2031

    in 5 yr

  4. Patent 8802142*PED expires

    Listed listed patent expiration.

    Dec 07, 2031

    in 5 yr 7 mo

Pharmaceutical detail

Active ingredient

LEVETIRACETAM

Strength

1GM

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 021035

Product number

004

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8802142Jun 07, 2031in 5 yr
Product
8802142*PEDDec 07, 2031in 5 yr 7 mo
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