Orange Book product · Brand (NDA)

OLEPTRO

TRAZODONE HYDROCHLORIDE

Brand (NDA)NDA 022411DISCN ANGELINI PHARMA

Feb 02, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 02, 2010
16 yr 7 mo ago
Today
Patent 7829120 expires
Listed drug product patent expiration.
Mar 27, 2027
in 9 mo
Patent 8133893 expires
Listed drug substance patent expiration.
Mar 13, 2029
in 2 yr 9 mo

Active ingredient

TRAZODONE HYDROCHLORIDE

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 022411

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
7829120	Mar 27, 2027	in 9 mo	ProductU-796
8133893	Mar 13, 2029	in 2 yr 9 mo	SubstanceProduct