Assyro AI

Orange Book product · Generic (ANDA)

NITAZOXANIDE

NITAZOXANIDE

Generic (ANDA)ANDA 214844TE ABRX ANI PHARMS

At a glance

Feb 03, 2025

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 03, 2025

    1 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NITAZOXANIDE

Strength

500MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 214844

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NITAZOXANIDE

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.