Orange Book product · Brand (NDA)

CAPRELSA

VANDETANIB

Brand (NDA)NDA 022405RX GENZYME CORP

Apr 06, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 06, 2011
15 yr 5 mo ago
Today
Patent 8067427 expires
Listed drug product patent expiration.
Aug 08, 2028
in 2 yr 2 mo

Active ingredient

VANDETANIB

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022405

Product number

001

Marketing status

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
8067427	Aug 08, 2028	in 2 yr 2 mo	Product