Assyro AI

Orange Book product · Generic (ANDA)

LEVOTHYROXINE SODIUM

LEVOTHYROXINE SODIUM

Generic (ANDA)ANDA 216729TE APRX ONESOURCE SPECIALTY

At a glance

Mar 05, 2025

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 05, 2025

    1 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVOTHYROXINE SODIUM

Strength

100MCG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

AP

Application

ANDA 216729

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LEVOTHYROXINE SODIUM

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.