Orange Book product · Brand (NDA)

QDOLO

TRAMADOL HYDROCHLORIDE

Brand (NDA)NDA 214044DISCN ROSEMONT

Sep 01, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 01, 2020
5 yr 11 mo ago
Today
Patent 11103452 expires
Listed drug product patent expiration.
Sep 01, 2040
in 14 yr 5 mo
Patent 11752103 expires
Listed drug product patent expiration.
Sep 01, 2040
in 14 yr 5 mo

Active ingredient

TRAMADOL HYDROCHLORIDE

Strength

5MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 214044

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
11103452	Sep 01, 2040	in 14 yr 5 mo	ProductU-3197
11752103	Sep 01, 2040	in 14 yr 5 mo	ProductU-3197