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Orange Book product · Generic (ANDA)

FENOFIBRIC ACID

CHOLINE FENOFIBRATE

Generic (ANDA)ANDA 212598TE ABRX AUROBINDO PHARMA LTD
View CHOLINE FENOFIBRATE familyOpen on FDA Orange Book

At a glance

Jul 25, 2019

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 25, 2019

    7 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

CHOLINE FENOFIBRATE

Strength

EQ 135MG FENOFIBRIC ACID

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 212598

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of CHOLINE FENOFIBRATE

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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