Assyro AI

Orange Book product · Brand (NDA)

AXID

NIZATIDINE

Brand (NDA)NDA 019508DISCN SMITHKLINE BEECHAM
View NIZATIDINE familyOpen on FDA Orange Book

At a glance

Apr 12, 1988

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 12, 1988

    38 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NIZATIDINE

Strength

300MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 019508

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active 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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo