Orange Book product · Brand (NDA)
FLUORINE F-18
SODIUM FLUORIDE F-18
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
SODIUM FLUORIDE F-18
Strength
2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 017042
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.
- 2011SODIUM FLUORIDE F 18Brand (NDA)
NDA 022494 · NIH NCI DCTD
- 2022SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 216126 · BAMF
- 2016SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 203936 · KREITCHMAN PET CTR
- 2015SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 204440 · MIDWEST MEDCL
- 2015SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 204462 · UIHC PET IMAGING
- 2015SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 203968 · JUBILANT DRAXIMAGE
- 2015SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 203777 · 3D IMAGING DRUG
- 2015SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 203890 · PETNET
- 2015SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 203592 · SOFIE
- 2015SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 203780 · CARDINAL HEALTH 414
- 2015SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 204530 · HOT SHOTS NM LLC
- 2015SODIUM FLUORIDE F-18Generic (ANDA)
ANDA 204517 · 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.
