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Last Updated: January 30, 2026

Details for New Drug Application (NDA): 203778

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NDA 203778 describes FLUDEOXYGLUCOSE F18, which is a drug marketed by Downstate Clincl, 3d Imaging Drug, Bamf, Biomedcl Res Fdn, Brigham Womens, Cardinal Health 414, Childrens Hosp Mi, Essential Isotopes, Feinstein, Hot Shots Nm Llc, Isologic Innovative, Jubilant Draximage, Kettering Medctr, Kreitchman Pet Ctr, Ma General Hosp, Mcprf, Mem Sloan-kettering, Methodist Hosp Res, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Northland, Nukemed, Petnet, Pharmalogic, Pharmalogic Hldgs, Precision Nuclear, Queen Hamamatsu Pet, Sofie, Trustees Univ Pa, Ucla Biomedical, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Michigan, Univ Southern Ca, Univ Tx Md Anderson, Univ Tx Sw Medctr, Univ Utah Cyclotron, Weill Medcl Coll, Wisconsin, and Wusm Cyclotron, and is included in forty-four NDAs. It is available from twenty-five suppliers. Additional details are available on the FLUDEOXYGLUCOSE F18 profile page.

The generic ingredient in FLUDEOXYGLUCOSE F18 is fludeoxyglucose f-18. There are eight drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the fludeoxyglucose f-18 profile page.

Summary for 203778

Tradename:	FLUDEOXYGLUCOSE F18
Applicant:	3d Imaging Drug
Ingredient:	fludeoxyglucose f-18
Patents:	0

Pharmacology for NDA: 203778

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 203778

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203778	ANDA	3D Imaging Drug Design and Development LLC	76451-118	76451-118-10	10 mL in 1 VIAL, GLASS (76451-118-10)
FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203778	ANDA	3D Imaging Drug Design and Development LLC	76451-118	76451-118-30	30 mL in 1 VIAL, GLASS (76451-118-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	20-300mCi/ML
Approval Date:	Oct 30, 2015	TE:	AP	RLD:	No

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