Orange Book product · Brand (NDA)

LEVOTHYROXINE SODIUM

Brand (NDA)NDA 214253RX HIKMA

May 17, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 17, 2021
5 yr 2 mo ago
Today
Patent 11154498 expires
Listed drug product patent expiration.
Jul 20, 2036
in 10 yr 3 mo

Active ingredient

LEVOTHYROXINE SODIUM

Strength

100MCG/ML

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 214253

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11154498	Jul 20, 2036	in 10 yr 3 mo	Product