Assyro AI

Orange Book product · Brand (NDA)

RYBIX ODT

TRAMADOL HYDROCHLORIDE

Brand (NDA)NDA 021693DISCN SHIONOGI INC

At a glance

May 05, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 05, 2005

    21 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TRAMADOL HYDROCHLORIDE

Strength

50MG

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

TE code

Not listed

Application

NDA 021693

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.