Assyro AI

Orange Book product · Generic (ANDA)

SODIUM IODIDE I 131

SODIUM IODIDE I-131

Generic (ANDA)ANDA 209166TE AARX INTL ISOTOPES

At a glance

Feb 05, 2020

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 05, 2020

    6 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SODIUM IODIDE I-131

Strength

250-1000mCi

Dosage form

SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 209166

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of SODIUM IODIDE I-131

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.