Orange Book product · Brand (NDA)

LEVOTHYROXINE SODIUM

Brand (NDA)NDA 210632RX FRESENIUS KABI USA

Apr 11, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 11, 2019
7 yr 4 mo ago
Today
Patent 10398669 expires
Listed drug product patent expiration.
Dec 01, 2036
in 10 yr 7 mo
Patent 11135190 expires
Listed drug product patent expiration.
Dec 01, 2036
in 10 yr 7 mo
Patent 9782376 expires
Listed drug product patent expiration.
Dec 01, 2036
in 10 yr 7 mo

Active ingredient

LEVOTHYROXINE SODIUM

Strength

100MCG/5ML (20MCG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 210632

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
10398669	Dec 01, 2036	in 10 yr 7 mo	Product
11135190	Dec 01, 2036	in 10 yr 7 mo	Product
9782376	Dec 01, 2036	in 10 yr 7 mo	Product