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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 203591

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NDA 203591 describes FLUDEOXYGLUCOSE F18, which is a drug marketed by Downstate Clincl, 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens, Cardinal Health 414, Childrens Hosp Mi, Decatur, 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-three NDAs. It is available from twenty-six 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-six suppliers are listed for this compound. Additional details are available on the fludeoxyglucose f-18 profile page.

Summary for 203591

Tradename:	FLUDEOXYGLUCOSE F18
Applicant:	Sofie
Ingredient:	fludeoxyglucose f-18
Patents:	0

Pharmacology for NDA: 203591

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 203591

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203591	ANDA	SOFIE Co.	49609-101	49609-101-01	30 mL in 1 VIAL, MULTI-DOSE (49609-101-01)
FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203591	ANDA	SOFIE Co.	49609-101	49609-101-02	50 mL in 1 VIAL, MULTI-DOSE (49609-101-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	20-300mCi/ML
Approval Date:	Aug 31, 2015	TE:	AP	RLD:	No

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