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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 204328


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NDA 204328 describes SODIUM FLUORIDE F-18, which is a drug marketed by 3d Imaging Drug, Bamf, Biomedcl Res Fdn, Cardinal Health 414, Decatur, Essential Isotopes, Hot Shots Nm Llc, Jubilant Draximage, Kreitchman Pet Ctr, Mcprf, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Nukemed, Petnet, Precision Nuclear, Shertech Labs Llc, Sofie, The Feinstein Inst, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Tx Md Anderson, and Univ Utah Cyclotron, and is included in twenty-four NDAs. It is available from ten suppliers. Additional details are available on the SODIUM FLUORIDE F-18 profile page.

The generic ingredient in SODIUM FLUORIDE F-18 is sodium fluoride f-18. There are one thousand four hundred and seventy-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sodium fluoride f-18 profile page.
Summary for 204328
Tradename:SODIUM FLUORIDE F-18
Applicant:The Feinstein Inst
Ingredient:sodium fluoride f-18
Patents:0
Pharmacology for NDA: 204328
Mechanism of ActionRadiopharmaceutical Activity
Medical Subject Heading (MeSH) Categories for 204328
Suppliers and Packaging for NDA: 204328
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM FLUORIDE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 204328 ANDA THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH 13267-542 13267-542-42 20 mL in 1 VIAL, GLASS (13267-542-42)
SODIUM FLUORIDE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 204328 ANDA BAMF Health Inc. 81759-002 81759-002-30 1 VIAL, GLASS in 1 CONTAINER (81759-002-30) / 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength20-600mCi/ML
Approval Date:Nov 19, 2014TE:RLD:No

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