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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 203777

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NDA 203777 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 203777

Tradename:	SODIUM FLUORIDE F-18
Applicant:	3d Imaging Drug
Ingredient:	sodium fluoride f-18
Patents:	0

Pharmacology for NDA: 203777

Mechanism of Action	Radiopharmaceutical Activity

Medical Subject Heading (MeSH) Categories for 203777

Cariostatic Agents

Suppliers and Packaging for NDA: 203777

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	203777	ANDA	3D Imaging Drug Design and Development LLC	76451-018	76451-018-10	10 mL in 1 VIAL, GLASS (76451-018-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	10-200mCi/ML
Approval Date:	Oct 19, 2015	TE:	AP	RLD:	No

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