Orange Book product · Brand (NDA)

LOREEV XR

LORAZEPAM

Brand (NDA)NDA 214826RX ALMATICA

Aug 27, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 27, 2021
4 yr 11 mo ago
Today
Patent 8999393 expires
Listed drug product patent expiration.
Jan 08, 2034
in 7 yr 8 mo

Active ingredient

LORAZEPAM

Strength

3MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 214826

Product number

003

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
8999393	Jan 08, 2034	in 7 yr 8 mo	ProductU-3210