Orange Book product · Brand (NDA)

ANTARA (MICRONIZED)

FENOFIBRATE

Brand (NDA)NDA 021695DISCN LUPIN

Oct 18, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 18, 2013
12 yr 10 mo ago
Today
Patent 9314447 expires
Listed drug product patent expiration.
May 31, 2033
in 7 yr 1 mo
Patent 9314447 expires
Listed drug product patent expiration.
May 31, 2033
in 7 yr 1 mo

Active ingredient

FENOFIBRATE

Strength

90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 021695

Product number

005

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
9314447	May 31, 2033	in 7 yr 1 mo	ProductU-1447
9314447	May 31, 2033	in 7 yr 1 mo	ProductU-1448