Orange Book product · Brand (NDA)

LEVOTHYROXINE SODIUM

Brand (NDA)NDA 202231TE APRX FRESENIUS KABI USA

Jun 24, 2011

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 24, 2011
15 yr 2 mo ago
Today
Patent 9168238 expires
Listed drug product patent expiration.
Aug 29, 2032
in 6 yr 3 mo
Patent 9168239 expires
Listed drug product patent expiration.
Aug 29, 2032
in 6 yr 3 mo
Patent 9006289 expires
Listed drug product patent expiration.
Oct 03, 2032
in 6 yr 5 mo

Active ingredient

LEVOTHYROXINE SODIUM

Strength

100MCG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Application

NDA 202231

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
9168238	Aug 29, 2032	in 6 yr 3 mo	Product
9168239	Aug 29, 2032	in 6 yr 3 mo	Product
9006289	Oct 03, 2032	in 6 yr 5 mo	Product