Assyro AI

Orange Book product · Generic (ANDA)

AMIFOSTINE

AMIFOSTINE

Generic (ANDA)ANDA 204363DISCN EUGIA PHARMA SPECLTS

At a glance

Jul 17, 2017

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 17, 2017

    9 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMIFOSTINE

Strength

500MG/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 204363

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AMIFOSTINE

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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