Orange Book product · Brand (NDA)
AMYVID
FLORBETAPIR F-18
Brand (NDA)NDA 202008DISCN AVID RADIOPHARMS INC
At a glance
Apr 06, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 06, 2012
14 yr 5 mo ago
Today
Patent 7687052 expires
Listed drug substance patent expiration.
Apr 30, 2027
in 11 mo
Patent 8506929 expires
Listed drug substance patent expiration.
Apr 30, 2027
in 11 mo
Pharmaceutical detail
Active ingredient
FLORBETAPIR F-18
Strength
10ML (13.5-51mCi/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 202008
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7687052 | Apr 30, 2027 | in 11 mo | SubstanceProductU-4217 |
| 8506929 | Apr 30, 2027 | in 11 mo | SubstanceProductU-4217 |
