Orange Book product · Brand (NDA)
FLUDEOXYGLUCOSE F18
FLUDEOXYGLUCOSE F-18
At a glance
Aug 19, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 19, 1994
32 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUDEOXYGLUCOSE F-18
Strength
4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020306
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.
- 2005FLUDEOXYGLUCOSE F18Brand (NDA)
NDA 021870 · FEINSTEIN
- 2004FLUDEOXYGLUCOSE F18Brand (NDA)
NDA 021768 · WEILL MEDCL COLL
- 2025FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 216125 · BAMF
- 2020FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 209341 · UNIV SOUTHERN CA
- 2020FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 210265 · UNIV TX SW MEDCTR
- 2016FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 208679 · MEM SLOAN-KETTERING
- 2016FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 203942 · KREITCHMAN PET CTR
- 2015FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 203736 · MIDWEST MEDCL
- 2015FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 203603 · CARDINAL HEALTH 414
- 2015FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 203778 · 3D IMAGING DRUG
- 2015FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 204759 · KETTERING MEDCTR
- 2015FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 204472 · MIPS CRF
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
