Orange Book product · Brand (NDA)

TIROSINT

LEVOTHYROXINE SODIUM

Brand (NDA)NDA 021924RX IBSA

Apr 25, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 25, 2017
9 yr 3 mo ago
Today
Patent 12564565 expires
Listed drug product patent expiration.
Sep 26, 2044
in 18 yr 6 mo

Active ingredient

LEVOTHYROXINE SODIUM

Strength

0.2MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 021924

Product number

012

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
12564565	Sep 26, 2044	in 18 yr 6 mo	Product