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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 203544

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NDA 203544 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 203544

Tradename:	SODIUM FLUORIDE F-18
Applicant:	Sofie
Ingredient:	sodium fluoride f-18
Patents:	0

Medical Subject Heading (MeSH) Categories for 203544

Cariostatic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	10-200mCi/ML
Approval Date:	Dec 26, 2012	TE:		RLD:	No

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