Assyro AI

Orange Book product · Brand (NDA)

ALINIA

NITAZOXANIDE

Brand (NDA)NDA 021498DISCN ROMARK
View NITAZOXANIDE familyOpen on FDA Orange Book

At a glance

Nov 22, 2002

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 22, 2002

    23 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NITAZOXANIDE

Strength

100MG/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 021498

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.

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