Orange Book product · Brand (NDA)

TAUVID

FLORTAUCIPIR F-18

Brand (NDA)NDA 212123DISCN AVID RADIOPHARMS INC

May 28, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 28, 2020
6 yr 2 mo ago
Today
Patent 8932557 expires
Listed drug substance patent expiration.
May 26, 2032
in 6 yr

Active ingredient

FLORTAUCIPIR F-18

Strength

30ML (8.1-51mCi/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 212123

Product number

001

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
8932557	May 26, 2032	in 6 yr	Substance