Assyro AI

Orange Book product · Generic (ANDA)

LEVETIRACETAM

LEVETIRACETAM

Generic (ANDA)ANDA 091291DISCN CHARTWELL RX

At a glance

Sep 12, 2011

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 12, 2011

    15 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVETIRACETAM

Strength

500MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 091291

Product number

001

Marketing status

DISCN

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.