Orange Book product · Brand (NDA)

SUPRAX

CEFIXIME

Brand (NDA)NDA 202091TE ABRX LUPIN LTD

Feb 20, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 20, 2013
13 yr 6 mo ago
Today
Patent 9233112 expires
Listed drug product patent expiration.
Dec 14, 2028
in 2 yr 6 mo

Active ingredient

CEFIXIME

Strength

500MG/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Application

NDA 202091

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
9233112	Dec 14, 2028	in 2 yr 6 mo	ProductU-1676