Assyro AI

Orange Book product · Generic (ANDA)

VIGABATRIN

VIGABATRIN

Generic (ANDA)ANDA 215707TE ABRX ZYDUS LIFESCIENCES

At a glance

Jan 19, 2022

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 19, 2022

    4 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VIGABATRIN

Strength

500MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 215707

Product number

001

Marketing status

RX

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.