Details for New Drug Application (NDA): 204351

NDA 204351 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 204351

Tradename:	SODIUM FLUORIDE F-18
Applicant:	Biomedcl Res Fdn
Ingredient:	sodium fluoride f-18
Patents:	0

Pharmacology for NDA: 204351

Mechanism of Action

Radiopharmaceutical Activity

Medical Subject Heading (MeSH) Categories for 204351

Cariostatic Agents

Suppliers and Packaging for NDA: 204351

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204351	ANDA	Biomedical Research Foundation of Northwest Louisiana	24562-002	24562-002-30	30 mL in 1 VIAL, MULTI-DOSE (24562-002-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	10-200mCi/ML
Approval Date:	Jan 9, 2015	TE:	AP	RLD:	No

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