Orange Book product · Brand (NDA)

RALDESY

TRAZODONE HYDROCHLORIDE

Brand (NDA)NDA 218637RX KAMAT

Nov 26, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 26, 2024
1 yr 7 mo ago
Today
Patent 8133893 expires
Listed drug substance patent expiration.
Mar 13, 2029
in 2 yr 9 mo

Active ingredient

TRAZODONE HYDROCHLORIDE

Strength

10MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 218637

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
8133893	Mar 13, 2029	in 2 yr 9 mo	SubstanceProduct