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Orange Book product · Generic (ANDA)

VIGABATRIN

VIGABATRIN

Generic (ANDA)ANDA 213375TE AARX ALKEM LABS LTD
View VIGABATRIN familyOpen on FDA Orange Book

At a glance

Dec 02, 2020

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 02, 2020

    5 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VIGABATRIN

Strength

500MG/PACKET

Dosage form

FOR SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 213375

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

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