Assyro AI

Orange Book product · Brand (NDA)

THYQUIDITY

LEVOTHYROXINE SODIUM

Brand (NDA)NDA 214047RX STEVENS J

At a glance

Nov 30, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

1

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 30, 2020

    5 yr 8 mo ago

  2. Today

  3. Patent 9050307 expires

    Listed drug product patent expiration.

    Aug 06, 2031

    in 5 yr 2 mo

Pharmaceutical detail

Active ingredient

LEVOTHYROXINE SODIUM

Strength

100MCG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 214047

Product number

001

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 (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9050307Aug 06, 2031in 5 yr 2 mo
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.