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Orange Book product · Generic (ANDA)

FINGOLIMOD HYDROCHLORIDE

FINGOLIMOD HYDROCHLORIDE

Generic (ANDA)ANDA 207993TE ABRX APOTEX
View FINGOLIMOD HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Dec 18, 2020

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 18, 2020

    5 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FINGOLIMOD HYDROCHLORIDE

Strength

EQ 0.5MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 207993

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FINGOLIMOD HYDROCHLORIDE

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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