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FDA Orange Book · active-ingredient family

Sodium fluoride f-18

Sodium fluoride f-18 is approved as 2 brand and 24 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SODIUM FLUORIDE F 18 · NDA 022494

2

Brand (NDA)

24

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
SODIUM FLUORIDE F 18RLDNIH NCI DCTDNDA 022494—Jan 26, 2011
FLUORINE F-18RLDGE HEALTHCARENDA 017042—Approved Prior to Jan 1, 1982

Generic (ANDA) products (24)

ProductApplicantApplicationTEApproved
SODIUM FLUORIDE F-18BAMFANDA 216126APDec 06, 2022
SODIUM FLUORIDE F-18KREITCHMAN PET CTRANDA 203936APMay 19, 2016
SODIUM FLUORIDE F-18MIDWEST MEDCLANDA 204440APNov 17, 2015
SODIUM FLUORIDE F-18UIHC PET IMAGINGANDA 204462—Nov 17, 2015
SODIUM FLUORIDE F-18JUBILANT DRAXIMAGEANDA 203968APOct 23, 2015
SODIUM FLUORIDE F-183D IMAGING DRUGANDA 203777APOct 19, 2015
SODIUM FLUORIDE F-18PETNETANDA 203890APSep 28, 2015
SODIUM FLUORIDE F-18SOFIEANDA 203592APAug 18, 2015
SODIUM FLUORIDE F-18CARDINAL HEALTH 414ANDA 203780APJul 30, 2015
SODIUM FLUORIDE F-18HOT SHOTS NM LLCANDA 204530—Jul 29, 2015
SODIUM FLUORIDE F-18MIPS CRFANDA 204517APJul 21, 2015
SODIUM FLUORIDE F-18NUKEMEDANDA 203912—Apr 22, 2015
SODIUM FLUORIDE F-18UNIV UTAH CYCLOTRONANDA 204497APApr 20, 2015
SODIUM FLUORIDE F-18PRECISION NUCLEARANDA 204542APFeb 27, 2015
SODIUM FLUORIDE F-18BIOMEDCL RES FDNANDA 204351APJan 09, 2015
SODIUM FLUORIDE F-18NCM USA BRONX LLCANDA 204513APNov 28, 2014
SODIUM FLUORIDE F-18THE FEINSTEIN INSTANDA 204328—Nov 19, 2014
SODIUM FLUORIDE F-18ESSENTIAL ISOTOPESANDA 204541—Oct 29, 2014
SODIUM FLUORIDE F-18DECATURANDA 204464—Oct 21, 2014
SODIUM FLUORIDE F-18SHERTECH LABS LLCANDA 204315—Sep 22, 2014
SODIUM FLUORIDE F-18UCSF RODIOPHARMANDA 204437—Mar 13, 2014
SODIUM FLUORIDE F-18UNIV TX MD ANDERSONANDA 203247—Dec 23, 2013
SODIUM FLUORIDE F-18MCPRFANDA 203605—Jun 28, 2013
SODIUM FLUORIDE F-18SOFIEANDA 203544—Dec 26, 2012

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.

Sodium fluoride f-18 — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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