Assyro AI

Orange Book product · Generic (ANDA)

LEVETIRACETAM

LEVETIRACETAM

Generic (ANDA)ANDA 091491TE ABRX ZHEJIANG JINGXIN

At a glance

Dec 14, 2010

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 14, 2010

    15 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVETIRACETAM

Strength

1GM

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 091491

Product number

004

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LEVETIRACETAM

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.