Assyro AI

Orange Book product · Brand (NDA)

GLOFIL-125

IOTHALAMATE SODIUM I-125

Brand (NDA)NDA 017279RX ISOTEX

At a glance

Approved Prior to Jan 1, 1982

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

IOTHALAMATE SODIUM I-125

Strength

250-300uCi/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 017279

Product number

001

Marketing status

RX

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.