Orange Book product · Brand (NDA)

NEURACEQ

FLORBETABEN F-18

Brand (NDA)NDA 204677RX LANTHEUS

Mar 19, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 19, 2014
12 yr 5 mo ago
Today
Patent 7807135 expires
Listed drug substance patent expiration.
Mar 18, 2029
in 2 yr 9 mo
Patent 9308284 expires
Listed drug product patent expiration.
Jul 14, 2032
in 6 yr 2 mo

Active ingredient

FLORBETABEN F-18

Strength

1.4-135mCi/ML

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 204677

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
7807135	Mar 18, 2029	in 2 yr 9 mo	SubstanceProductU-1497
9308284	Jul 14, 2032	in 6 yr 2 mo	Product