Orange Book product · Brand (NDA)

METAXALONE

Brand (NDA)NDA 022503RX PRIMUS PHARMS

Jun 01, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 01, 2015
11 yr 3 mo ago
Today
Patent 11918559 expires
Listed drug product patent expiration.
Jul 29, 2039
in 13 yr 4 mo
Patent 12485111 expires
Listed drug product patent expiration.
May 14, 2043
in 17 yr 2 mo

Active ingredient

METAXALONE

Strength

640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022503

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
11918559	Jul 29, 2039	in 13 yr 4 mo	Product
12485111	May 14, 2043	in 17 yr 2 mo	ProductU-4453