Orange Book product · Brand (NDA)

NETSPOT

GALLIUM DOTATATE GA-68

Brand (NDA)NDA 208547RX AAA USA INC

Jun 01, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 01, 2016
10 yr 2 mo ago
Today
Patent 9375498 expires
Listed drug product patent expiration.
Aug 10, 2032
in 6 yr 3 mo

Active ingredient

GALLIUM DOTATATE GA-68

Strength

2.1-5.5mCi/ML

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 208547

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
9375498	Aug 10, 2032	in 6 yr 3 mo	Product