Assyro AI

Orange Book product · Brand (NDA)

TECHNELITE

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

Brand (NDA)NDA 017771RX SHINE

At a glance

Feb 12, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 12, 2014

    12 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

Strength

1-20 CI/GENERATOR

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 017771

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this 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.