Orange Book product · Brand (NDA)

IYUZEH

LATANOPROST

Brand (NDA)NDA 216472RX THEA PHARMA

Dec 13, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 13, 2022
3 yr 7 mo ago
Today
Patent 8637054 expires
Listed drug product patent expiration.
Jul 08, 2031
in 5 yr 2 mo

Active ingredient

LATANOPROST

Strength

0.005%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 216472

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
8637054	Jul 08, 2031	in 5 yr 2 mo	ProductU-446