Assyro AI

Orange Book product · Brand (NDA)

PRELAY

TROGLITAZONE

Brand (NDA)NDA 020719DISCN SANKYO

At a glance

Jan 29, 1997

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 29, 1997

    29 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TROGLITAZONE

Strength

200MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 020719

Product number

001

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.