Orange Book product · Brand (NDA)

VIZAMYL

FLUTEMETAMOL F-18

Brand (NDA)NDA 203137RX GE HEALTHCARE

Oct 25, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 25, 2013
12 yr 10 mo ago
Today
Patent 8916131 expires
Listed drug product patent expiration.
Sep 16, 2028
in 2 yr 3 mo

Active ingredient

FLUTEMETAMOL F-18

Strength

121.5mCi/30ML (4.05mCi/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 203137

Product number

002

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
8916131	Sep 16, 2028	in 2 yr 3 mo	Product