Assyro AI

Orange Book product · Generic (ANDA)

VIGABATRIN

VIGABATRIN

Generic (ANDA)ANDA 211790DISCN CHARTWELL RX

At a glance

Mar 10, 2022

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 10, 2022

    4 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VIGABATRIN

Strength

500MG/PACKET

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Not listed

Application

ANDA 211790

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of VIGABATRIN

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.