Orange Book product · Brand (NDA)

ERMEZA

LEVOTHYROXINE SODIUM

Brand (NDA)NDA 215809RX MYLAN

Apr 29, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 29, 2022
4 yr 2 mo ago
Today
Patent 9345772 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo

Active ingredient

LEVOTHYROXINE SODIUM

Strength

150MCG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 215809

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
9345772	Feb 27, 2035	in 8 yr 10 mo	Product